- What it does: Relu's Creator and Cloud products are FDA-cleared for managing and analyzing oral and maxillofacial images (CBCT and intraoral scans), with AI segmentation used as design input for implant, orthodontic and surgical planning.
- Regulatory: 2 FDA 510(k) clearances (K252708, K233925)
- Pricing: Not published (Per-case or subscription; quote via sales)
- Best fit: specialist, ortho, oral-surgery, dso
FDA clearances
What the FDA cleared, in the words of the decision. Anything not listed here is outside the clearance, even if the product does it.
| 510(k) | Device | Decision | Cleared for |
|---|---|---|---|
| K252708 | Relu Cloud | Apr 10, 2026 | Management and analysis of oral and maxillofacial images to support diagnosis and treatment planning; provides design input for dental solutions. |
| K233925 | Relu Creator | Jun 13, 2024 | Relu Creator: management and analysis of dental and craniomaxillofacial images; provides design input for dental solutions. |
Capabilities
Imaging modalities: CBCT, intraoral scan.
- Two FDA clearances (K233925, K252708) for 3D segmentation workflows
- Planning and design tool, not a chairside diagnostic detector
What we have not verified
We have not evaluated Relu. Pricing and integrations were not publicly confirmed at last verification.
Common questions
Is Relu FDA cleared?
Yes. Relu holds 2 FDA 510(k) clearances: K252708 (Apr 10, 2026) for management and analysis of oral and maxillofacial images to support diagnosis and treatment planning; provides design input for dental solutions.; K233925 (Jun 13, 2024) for relu Creator: management and analysis of dental and craniomaxillofacial images; provides design input for dental solutions.. Features outside those indications are not covered by the clearance.
How much does Relu cost?
Relu does not publish pricing; it is quoted by sales (Per-case or subscription; quote via sales).