510(k) K213343
K213343 is an FDA 510(k) premarket notification submitted by Saremco Dental AG for the device "Saremco Print CROWNTEC". The FDA issued a decision of Substantially Equivalent on January 21, 2022. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Saremco Dental AG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 2022
- Date Received
- October 7, 2021
- Clearance Type
- Abbreviated
- 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