The following data is part of a premarket notification filed by Novamin Technology, Inc. with the FDA for Oralief Otc Toothpaste For Sensitive Teeth.
| Device ID | K080228 |
| 510k Number | K080228 |
| Device Name: | ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH |
| Classification | Varnish, Cavity |
| Applicant | NOVAMIN TECHNOLOGY, INC. 13859 PROGRESS BLVD.,#600 Alachua, FL 32615 |
| Contact | Robert G Rothfritz |
| Correspondent | Robert G Rothfritz NOVAMIN TECHNOLOGY, INC. 13859 PROGRESS BLVD.,#600 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 | 2008-01-30 |
| Decision Date | 2008-03-27 |
| Summary: | summary |