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 |