The following data is part of a premarket notification filed by New Stetic with the FDA for New Stetic Artificial Teeth.
| Device ID | K122925 |
| 510k Number | K122925 |
| Device Name: | NEW STETIC ARTIFICIAL TEETH |
| Classification | Denture, Plastic, Teeth |
| Applicant | NEW STETIC 445 APOLLO BEACH BLVD Apollo Beach, FL 33572 |
| Contact | John Obrien |
| Correspondent | John Obrien NEW STETIC 445 APOLLO BEACH BLVD Apollo Beach, FL 33572 |
| Product Code | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-24 |
| Decision Date | 2013-02-12 |
| Summary: | summary |