510(k) K151088
K151088 is an FDA 510(k) premarket notification submitted by Danville Materials, LLC for the device "DMRC Bulk Fill". The FDA issued a decision of Substantially Equivalent on August 28, 2015. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Danville Materials, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2015
- Date Received
- April 23, 2015
- 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