The following data is part of a premarket notification filed by Novamin Technology, Inc. with the FDA for Oralief Therapy For Sensitive Teeth.
| Device ID | K040858 |
| 510k Number | K040858 |
| Device Name: | ORALIEF THERAPY FOR SENSITIVE TEETH |
| Classification | Varnish, Cavity |
| Applicant | NOVAMIN TECHNOLOGY, INC. 13709 PROGRESS BLVD., BOX #23 Alachua, FL 32615 |
| Contact | David C Greenspan |
| Correspondent | David C Greenspan NOVAMIN TECHNOLOGY, INC. 13709 PROGRESS BLVD., BOX #23 Alachua, FL 32615 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-02 |
| Decision Date | 2004-09-02 |
| Summary: | summary |