510(k) K221695
K221695 is an FDA 510(k) premarket notification submitted by 3M Company Espe Dental Products for the device "3M Filtek Supreme Flowable Restorative". The FDA issued a decision of Substantially Equivalent on Jun 13, 2022. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 13, 2022
- Date Received
- Jun 10, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Material, Tooth Shade, Resin
- Device Class
- Class II
- Regulation Number
- 872.3690
- Review Panel
- DE
- Submission Type
- 510(k)