510(k) K222435
K222435 is an FDA 510(k) premarket notification submitted by Cosmedent, Inc. for the device "Renamel® Microhybrid ;Renamel® Flowable Microhybrid". The FDA issued a decision of Substantially Equivalent on Oct 11, 2022. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Cosmedent, Inc. has 27 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 11, 2022
- Date Received
- Aug 12, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Material, Tooth Shade, Resin
- Device Class
- Class II
- Regulation Number
- 872.3690
- Review Panel
- DE
- Submission Type
- 510(k)