The following data is part of a premarket notification filed by Dentsply International Inc. with the FDA for Nupro Sensodyne Prophylaxis Paste With Novamin.
| Device ID | K121698 |
| 510k Number | K121698 |
| Device Name: | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | DENTSPLY INTERNATIONAL INC. 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL INC. 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-08 |
| Decision Date | 2012-08-06 |
| Summary: | summary |