The following data is part of a premarket notification filed by Novamin Technology, Inc. with the FDA for Oravive Tooth Revitalizing Paste.
Device ID | K040473 |
510k Number | K040473 |
Device Name: | ORAVIVE TOOTH REVITALIZING PASTE |
Classification | Varnish, Cavity |
Applicant | NOVAMIN TECHNOLOGY, INC. 13709 PROGRESS BLVD, # 23 Alachua, FL 32615 |
Contact | David C Greenspan |
Correspondent | David C Greenspan NOVAMIN TECHNOLOGY, INC. 13709 PROGRESS BLVD, # 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 | 2004-02-24 |
Decision Date | 2004-03-10 |
Summary: | summary |