510(k) K262681
K262681 is an FDA 510(k) premarket notification submitted by 3BFAB TEKNOLOJI A.S. for the device "NanoCeram Resin". The FDA issued a decision of Substantially Equivalent on July 31, 2026. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2026
- Date Received
- July 30, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Resin, Denture, Relining, Repairing, Rebasing
- Device Class
- Class II
- Regulation Number
- 872.3760
- Review Panel
- DE
- Submission Type