510(k) K222723
K222723 is an FDA 510(k) premarket notification submitted by Creamed GmbH & Co. Produktions- Und Handels KG for the device "AMBARINO High-Class". The FDA issued a decision of Substantially Equivalent on Sep 9, 2022. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 9, 2022
- Date Received
- Sep 8, 2022
- 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
- 510(k)