510(k) K183476
K183476 is an FDA 510(k) premarket notification submitted by 3M Espe Dental Products for the device "3M Filtek Universal Restorative". The FDA issued a decision of Substantially Equivalent on January 2, 2019. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. 3M Espe Dental Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 2, 2019
- Date Received
- December 17, 2018
- 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