510(k) K190758
K190758 is an FDA 510(k) premarket notification submitted by Dentscare Ltda for the device "Opus Bulk Fill APS, Opus Bulk Fill Flow APS". The FDA issued a decision of Substantially Equivalent on September 4, 2019. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Dentscare Ltda has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 2019
- Date Received
- March 25, 2019
- 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