510(k) K242097
K242097 is an FDA 510(k) premarket notification submitted by Den-Mat Holdings, LLC for the device "DenMat Bulk Fill Composite". The FDA issued a decision of Substantially Equivalent on October 15, 2024. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Den-Mat Holdings, LLC has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2024
- Date Received
- July 18, 2024
- 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