510(k) K220097
K220097 is an FDA 510(k) premarket notification submitted by Coltène/Whaledent AG for the device "PRESIDENT The Original". The FDA issued a decision of Substantially Equivalent on January 13, 2022. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2022
- Date Received
- January 12, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type