The following data is part of a premarket notification filed by Novamin Technology, Inc. with the FDA for Butler Nucare Root Conditioner With Novamin.
| Device ID | K033295 |
| 510k Number | K033295 |
| Device Name: | BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN |
| Classification | Varnish, Cavity |
| Applicant | NOVAMIN TECHNOLOGY, INC. 13709 PROGRESS BLVD, # 23 Alachua, FL 32615 |
| Contact | David C Greenspan |
| Correspondent | Harry Van Vugt N.V. KEMA P.O. BOX 9035 6800 ET ARNHEM Arnhem, NL |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-10-14 |
| Decision Date | 2003-10-28 |
| Summary: | summary |