The following data is part of a premarket notification filed by Novamin Technology, Inc. with the FDA for Periosrp Tooth Root Conditioner With Novamin.
Device ID | K071267 |
510k Number | K071267 |
Device Name: | PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN |
Classification | Varnish, Cavity |
Applicant | NOVAMIN TECHNOLOGY, INC. 13709 PROGRESS BLVD., STE. 23 Alachua, FL 32615 |
Contact | Robert G Rothfritz |
Correspondent | Robert G Rothfritz NOVAMIN TECHNOLOGY, INC. 13709 PROGRESS BLVD., STE. 23 Alachua, FL 32615 |
Product Code | LBH |
CFR Regulation Number | 872.3260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-05-07 |
Decision Date | 2007-05-18 |