510(k) K122852
K122852 is an FDA 510(k) premarket notification submitted by Candulor USA, Inc. for the device "PHYSIOSTAR NFC". The FDA issued a decision of Substantially Equivalent on December 6, 2012. The device falls under product code ELM (Denture, Plastic, Teeth), a Class II device regulated under 21 CFR 872.3590. Candulor USA, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 2012
- Date Received
- September 18, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Denture, Plastic, Teeth
- Device Class
- Class II
- Regulation Number
- 872.3590
- Review Panel
- DE
- Submission Type