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 |