510(k) K190597
K190597 is an FDA 510(k) premarket notification submitted by Coltene/Whaledent AG for the device "BRILLIANT EverGlow Flow". The FDA issued a decision of Substantially Equivalent on Jun 21, 2019. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Coltene/Whaledent AG has 37 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 21, 2019
- Date Received
- Mar 7, 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
- 510(k)