The following data is part of a premarket notification filed by Candulor Usa, Inc. with the FDA for Physiostar Nfc.
| Device ID | K122852 |
| 510k Number | K122852 |
| Device Name: | PHYSIOSTAR NFC |
| Classification | Denture, Plastic, Teeth |
| Applicant | CANDULOR USA, INC. 175 PINEVIEW DRIVE Amherst, NY 14228 |
| Contact | Donna Marie Hartnett |
| Correspondent | Donna Marie Hartnett CANDULOR USA, INC. 175 PINEVIEW DRIVE Amherst, NY 14228 |
| Product Code | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-18 |
| Decision Date | 2012-12-06 |