{
 "title": "FDA-cleared dental AI: 510(k) clearances",
 "publisher": "AI Dental Tools",
 "url": "https://aidentaltools.com/clinical-ai/dental-ai-fda-clearance-tracker/",
 "license": "https://creativecommons.org/licenses/by/4.0/",
 "attribution": "AI Dental Tools (https://aidentaltools.com/clinical-ai/dental-ai-fda-clearance-tracker/)",
 "verified": "2026-10-26",
 "sources": [
  "https://open.fda.gov/apis/device/510k/",
  "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
 ],
 "clearanceCount": 55,
 "companyCount": 20,
 "clearances": [
  {
   "k_number": "K262196",
   "company": "Align Technology",
   "applicant": "Align Technology, Inc.",
   "device": "Invisalign System",
   "decision_date": "2026-09-25",
   "product_code": "PNN",
   "imaging": "other",
   "image_types": "intraoral scan",
   "findings": "treatment planning / design",
   "cleared_for": "Invisalign System: adds an optional AI-enabled prediction service to Invisalign's 3D treatment-planning software to optimize aligner activation design; the doctor reviews and approves each plan.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K262196.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262196",
   "profile": ""
  },
  {
   "k_number": "K262127",
   "company": "Dentsply Sirona",
   "applicant": "Dentsply Sirona",
   "device": "DS Core CBCT Anatomy",
   "decision_date": "2026-08-21",
   "product_code": "QIH",
   "imaging": "CBCT; other",
   "image_types": "CBCT; intraoral scan",
   "findings": "anatomy; treatment planning / design",
   "cleared_for": "Segments anatomy on CBCT scans and intraoral (digital impression) scans for diagnostic review and treatment planning (updated clearance).",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K262127.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262127",
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  },
  {
   "k_number": "K261059",
   "company": "Overjet",
   "applicant": "Overjet, Inc.",
   "device": "Overjet Multi-Image Caries and Charting Assist",
   "decision_date": "2026-08-06",
   "product_code": "MYN",
   "imaging": "2D",
   "image_types": "bitewing; periapical; panoramic",
   "findings": "caries; restorations / charting; anatomy",
   "cleared_for": "Multi-Image Caries and Charting Assist: reads all of a patient's radiographs together. Detects and outlines caries (incipient, non-incipient, secondary) on bitewings and periapicals, and tooth anatomy, tooth numbers and past restorations on bitewing, periapical and panoramic radiographs, patients 4 and older.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K261059.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261059",
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  },
  {
   "k_number": "K254096",
   "company": "Velmeni",
   "applicant": "Velmeni, Inc.",
   "device": "VELMENI for DENTISTS (V4D) 3D",
   "decision_date": "2026-07-23",
   "product_code": "QIH",
   "imaging": "CBCT",
   "image_types": "CBCT",
   "findings": "anatomy",
   "cleared_for": "VELMENI for DENTISTS (V4D) 3D: concurrent-read detection of anatomical structures (jaws, mandibular canal, TMJ, maxillary sinus, teeth, airway) on CBCT scans of permanent teeth, patients 15 and older.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K254096.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254096",
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  },
  {
   "k_number": "K260851",
   "company": "Better Diagnostics AI",
   "applicant": "Better Diagnostics AI Corp.",
   "device": "Better Diagnostics Dental Assist (BDDA) Version 1.0",
   "decision_date": "2026-07-15",
   "product_code": "MYN",
   "imaging": "2D",
   "image_types": "bitewing; periapical",
   "findings": "periapical radiolucency; bone level; calculus",
   "cleared_for": "Measures mesial and distal bone levels and marks suspected findings (marginal discrepancy, calculus, periapical radiolucency and more) on bitewing and periapical radiographs.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260851.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260851",
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  },
  {
   "k_number": "K252953",
   "company": "Velmeni",
   "applicant": "Velmeni, Inc.",
   "device": "Velmeni for Dentists (V4D)  Endo-Perio",
   "decision_date": "2026-05-11",
   "product_code": "MYN",
   "imaging": "2D",
   "image_types": "bitewing; periapical; panoramic",
   "findings": "bone level; restorations / charting; anatomy",
   "cleared_for": "VELMENI for DENTISTS (V4D) Endo-Perio: concurrent-read detection of tooth anatomy (enamel, dentine, pulp, root), jaw anatomy (mental foramen, inferior alveolar canal, maxillary sinus), bone level (CEJ and crestal bone) and root-canal-treated teeth on bitewing, periapical and panoramic radiographs, permanent teeth, patients 15 and older.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252953.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252953",
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  },
  {
   "k_number": "K260419",
   "company": "ChohoTech",
   "applicant": "Hangzhou ChohoTech Co., Ltd.",
   "device": "LingOral Dental Design System",
   "decision_date": "2026-05-08",
   "product_code": "PNN",
   "imaging": "other",
   "image_types": "intraoral scan",
   "findings": "treatment planning / design",
   "cleared_for": "LingOral Dental Design System: treatment-planning simulations and design of crowns, bridges, veneers, inlays/onlays and clear aligners from 3D mesh (intraoral scan) data.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260419.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260419",
   "profile": ""
  },
  {
   "k_number": "K260785",
   "company": "Dentsply Sirona",
   "applicant": "Dentsply Sirona",
   "device": "DS Core CBCT Anatomy",
   "decision_date": "2026-04-23",
   "product_code": "QIH",
   "imaging": "CBCT; other",
   "image_types": "CBCT; intraoral scan",
   "findings": "anatomy; treatment planning / design",
   "cleared_for": "Cloud AI service that segments anatomy on CBCT scans and intraoral (digital impression) scans for diagnostic review and treatment planning.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260785.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260785",
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  },
  {
   "k_number": "K260082",
   "company": "3Shape",
   "applicant": "3Shape TRIOS A/S",
   "device": "TRIOS Dx (R1)",
   "decision_date": "2026-04-10",
   "product_code": "SHQ",
   "imaging": "other",
   "image_types": "intraoral scan",
   "findings": "caries; tooth wear / gingiva / plaque",
   "cleared_for": "TRIOS Dx: aid in diagnosing and tracking caries, tooth wear, gingival recession and plaque from TRIOS intraoral scans.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260082.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260082",
   "profile": ""
  },
  {
   "k_number": "K253930",
   "company": "Overjet",
   "applicant": "Overjet, Inc.",
   "device": "Overjet Iris Intelligent Imaging System",
   "decision_date": "2026-04-10",
   "product_code": "QIH",
   "imaging": "2D",
   "image_types": "bitewing; periapical; panoramic",
   "findings": "image processing / management",
   "cleared_for": "Web-based image management (PACS): acquires, stores, displays and shares dental images from intraoral sensors and panoramic units.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253930.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253930",
   "profile": "https://aidentaltools.com/tools/overjet/"
  },
  {
   "k_number": "K252708",
   "company": "Relu",
   "applicant": "Relu BV",
   "device": "Relu Cloud",
   "decision_date": "2026-04-10",
   "product_code": "QIH",
   "imaging": "CBCT; other",
   "image_types": "CBCT; intraoral scan",
   "findings": "treatment planning / design",
   "cleared_for": "Management and analysis of oral and maxillofacial images to support diagnosis and treatment planning; provides design input for dental solutions.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252708.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252708",
   "profile": "https://aidentaltools.com/tools/relu/"
  },
  {
   "k_number": "K252538",
   "company": "Orca Dental AI",
   "applicant": "Orca Dental AI , Ltd.",
   "device": "CEPHX3D",
   "decision_date": "2026-03-05",
   "product_code": "QIH",
   "imaging": "2D; CBCT",
   "image_types": "CBCT; cephalometric",
   "findings": "cephalometric analysis; treatment planning / design",
   "cleared_for": "CephX3D: analysis of dental and craniomaxillofacial images (including 3D) to support diagnosis and treatment planning, for patients 12 and older.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252538.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252538",
   "profile": "https://aidentaltools.com/tools/orca-dental-ai/"
  },
  {
   "k_number": "K252934",
   "company": "Diagnocat",
   "applicant": "DGNCT, LLC",
   "device": "Diagnocat",
   "decision_date": "2026-01-15",
   "product_code": "MYN",
   "imaging": "CBCT",
   "image_types": "CBCT",
   "findings": "periapical radiolucency",
   "cleared_for": "Concurrent-read detection of periapical radiolucency on permanent teeth in CBCT scans, for patients 22 and older.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252934.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252934",
   "profile": "https://aidentaltools.com/tools/diagnocat/"
  },
  {
   "k_number": "K253009",
   "company": "Dentsply Sirona",
   "applicant": "Dentsply Sirona, Inc.",
   "device": "DS Core Detect",
   "decision_date": "2026-01-07",
   "product_code": "MYN",
   "imaging": "CBCT",
   "image_types": "CBCT",
   "findings": "periapical radiolucency",
   "cleared_for": "DS Core Detect: concurrent-read detection of permanent teeth that may have periapical radiolucency on CBCT scans already taken for other reasons, adults 22 and older.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253009.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253009",
   "profile": "https://aidentaltools.com/tools/dentsply-ds-core/"
  },
  {
   "k_number": "K251514",
   "company": "Overjet",
   "applicant": "Overjet, Inc.",
   "device": "Overjet CBCT Assist",
   "decision_date": "2025-12-05",
   "product_code": "QIH",
   "imaging": "CBCT",
   "image_types": "CBCT",
   "findings": "anatomy; image processing / management",
   "cleared_for": "AI segmentation, measurements and 2D/3D visualization of dental and craniomaxillofacial CBCT scans.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251514.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251514",
   "profile": "https://aidentaltools.com/tools/overjet/"
  },
  {
   "k_number": "K252086",
   "company": "Nobel Biocare",
   "applicant": "Nobel Biocare C/O Medicim NV",
   "device": "DTX Studio Assist",
   "decision_date": "2025-11-17",
   "product_code": "MYN",
   "imaging": "2D",
   "image_types": "bitewing; periapical",
   "findings": "caries; periapical radiolucency; bone level; calculus; restorations / charting; anatomy",
   "cleared_for": "DTX Studio Assist: SDK for imaging software that measures alveolar bone levels, segments restorations and anatomy, and flags caries, calculus, periapical radiolucency, root canal filling deficiency and restoration-margin discrepancy on bitewing and periapical radiographs, permanent teeth, patients 15 and older.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252086.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252086",
   "profile": ""
  },
  {
   "k_number": "K250525",
   "company": "Pearl",
   "applicant": "Pearl, Inc.",
   "device": "Second Opinion® Panoramic",
   "decision_date": "2025-11-14",
   "product_code": "MYN",
   "imaging": "2D",
   "image_types": "panoramic",
   "findings": "caries; periapical radiolucency; impacted third molars",
   "cleared_for": "Marks suspected caries, periapical radiolucency and impacted third molars on panoramic radiographs, patients 16 and older.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250525.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250525",
   "profile": "https://aidentaltools.com/tools/pearl/"
  },
  {
   "k_number": "K250264",
   "company": "Bench7",
   "applicant": "Bench7, Inc.",
   "device": "SugarBug (1.x)",
   "decision_date": "2025-11-07",
   "product_code": "MYN",
   "imaging": "2D",
   "image_types": "bitewing",
   "findings": "caries",
   "cleared_for": "SugarBug: concurrent-read detection and segmentation of caries on bitewing radiographs, patients 18 and older.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250264.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250264",
   "profile": ""
  },
  {
   "k_number": "K251002",
   "company": "VideaHealth",
   "applicant": "Videahealth, Inc.",
   "device": "Videa Dental AI",
   "decision_date": "2025-09-19",
   "product_code": "MYN",
   "imaging": "2D",
   "image_types": "bitewing; periapical; panoramic",
   "findings": "caries; periapical radiolucency; calculus; restorations / charting; anatomy",
   "cleared_for": "Videa Dental AI: computer-aided detection on bitewing, periapical and panoramic radiographs, patients 3 and older. Flags suspected caries, attrition, broken teeth, restorative imperfections, pulp stones, dens invaginatus, periapical radiolucency, widened periodontal ligament, furcation and calculus, plus past treatments (crowns, fillings, bridges, root canals, implants) and normal anatomy.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251002.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251002",
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  },
  {
   "k_number": "K251072",
   "company": "Diagnocat",
   "applicant": "DGNCT, LLC",
   "device": "Segmentron Viewer",
   "decision_date": "2025-09-09",
   "product_code": "QIH",
   "imaging": "CBCT",
   "image_types": "CBCT",
   "findings": "image processing / management",
   "cleared_for": "Segmentron Viewer: processing and 3D visualization of maxillofacial radiographic images; STL generation for educational purposes only.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251072.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251072",
   "profile": "https://aidentaltools.com/tools/diagnocat/"
  },
  {
   "k_number": "K250753",
   "company": "Velmeni",
   "applicant": "Velmeni, Inc.",
   "device": "VELMENI for DENTISTS (V4D)",
   "decision_date": "2025-09-02",
   "product_code": "MYN",
   "imaging": "2D",
   "image_types": "bitewing; periapical; panoramic",
   "findings": "caries; restorations / charting",
   "cleared_for": "VELMENI for DENTISTS (V4D), updated with a predetermined change control plan: concurrent-read detection of caries, fillings/restorations, fixed prostheses and implants on bitewing, periapical and panoramic radiographs, permanent teeth, patients 15 and older.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250753.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250753",
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  {
   "k_number": "K250755",
   "company": "Dentsply Sirona",
   "applicant": "Dentsply Sirona, Inc.",
   "device": "DS Core Diagnosis",
   "decision_date": "2025-08-12",
   "product_code": "QIH",
   "imaging": "2D",
   "image_types": "bitewing; periapical; panoramic",
   "findings": "image processing / management",
   "cleared_for": "DS Core Diagnosis: cloud viewer for reviewing and analyzing dental images and other patient media to support diagnosis. Its Panoramic Curve Proposal feature is for patients 12 and older with permanent dentition.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250755.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250755",
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  {
   "k_number": "K243234",
   "company": "Pearl",
   "applicant": "Pearl, Inc.",
   "device": "Second Opinion® CS",
   "decision_date": "2025-06-12",
   "product_code": "MYN",
   "imaging": "2D",
   "image_types": "periapical",
   "findings": "caries",
   "cleared_for": "Second Opinion CS: detection and segmentation of caries on periapical radiographs, permanent teeth, patients 12 and older (second reader).",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243234.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243234",
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  },
  {
   "k_number": "K243005",
   "company": "Audax",
   "applicant": "Audax D.O.O.",
   "device": "AudaxCeph Cephalogram Analysis Software",
   "decision_date": "2025-05-30",
   "product_code": "QIH",
   "imaging": "2D",
   "image_types": "cephalometric",
   "findings": "cephalometric analysis; treatment planning / design",
   "cleared_for": "AudaxCeph: cephalogram landmarking, tracing and measurement for orthodontic treatment planning. FDA lists it as AI-enabled.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243005.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243005",
   "profile": ""
  },
  {
   "k_number": "K250005",
   "company": "Ewoosoft",
   "applicant": "Ewoosoft Co., Ltd.",
   "device": "Clever One",
   "decision_date": "2025-05-23",
   "product_code": "QIH",
   "imaging": "2D; CBCT",
   "image_types": "CBCT; panoramic; cephalometric; bitewing; periapical",
   "findings": "cephalometric analysis; image processing / management",
   "cleared_for": "Clever One: dental imaging software for viewing and analyzing CT, panoramic, cephalometric and intraoral images in 2D and 3D. FDA lists it as AI-enabled; the public summary does not say which feature uses AI.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250005.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250005",
   "profile": ""
  },
  {
   "k_number": "K243989",
   "company": "Pearl",
   "applicant": "Pearl, Inc.",
   "device": "Second Opinion® 3D",
   "decision_date": "2025-05-23",
   "product_code": "QIH",
   "imaging": "CBCT",
   "image_types": "CBCT",
   "findings": "anatomy",
   "cleared_for": "Second Opinion 3D: marks anatomy on CBCT (dentition, maxilla, mandible, inferior alveolar canal, sinus, airway).",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243989.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243989",
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  },
  {
   "k_number": "K242437",
   "company": "Cube Click",
   "applicant": "Cube Click, Inc.",
   "device": "Smile Dx®",
   "decision_date": "2025-05-14",
   "product_code": "MYN",
   "imaging": "2D",
   "image_types": "bitewing; periapical",
   "findings": "caries; periapical radiolucency; bone level; restorations / charting; anatomy",
   "cleared_for": "Smile Dx: detection and segmentation of caries, periapical radiolucency, restorations and anatomy, plus mesial and distal bone-level measurement, on bitewing and periapical radiographs of permanent teeth.",
   "fda_pdf": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242437.pdf",
   "fda_record": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242437",
   "profile": ""
  },
  {
   "k_number": "K243230",
   "company": "Pearl",
   "applicant": "Pearl, Inc.",
   "device": "Second Opinion® BLE",
   "decision_date": "2025-05-09",
   "product_code": "QIH",
   "imaging": "2D",
   "image_types": "bitewing; periapical",
   "findings": "bone level",
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