The following data is part of a premarket notification filed by Novamin Technology, Inc. with the FDA for Butler Nucare Prophylaxis Paste With Novamin.
| Device ID | K041371 |
| 510k Number | K041371 |
| Device Name: | BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN |
| Classification | Agent, Polishing, Abrasive, Oral 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 | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-24 |
| Decision Date | 2004-08-23 |
| Summary: | summary |