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 |