510(k) K220329
K220329 is an FDA 510(k) premarket notification submitted by Graphenano Dental S.L. for the device "G-CAM". The FDA issued a decision of Substantially Equivalent on Aug 16, 2022. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Graphenano Dental S.L. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 16, 2022
- Date Received
- Feb 4, 2022
- Clearance Type
- Abbreviated
- 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