510(k) K122925
K122925 is an FDA 510(k) premarket notification submitted by New Stetic for the device "NEW STETIC ARTIFICIAL TEETH". The FDA issued a decision of Substantially Equivalent on February 12, 2013. The device falls under product code ELM (Denture, Plastic, Teeth), a Class II device regulated under 21 CFR 872.3590. New Stetic has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2013
- Date Received
- September 24, 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