The following data is part of a premarket notification filed by Discus Dental, Inc. with the FDA for Proactive Care Prophylaxis Paste With Fluoride.
| Device ID | K033785 |
| 510k Number | K033785 |
| Device Name: | PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | DISCUS DENTAL, INC. 8550 HIGUERA ST. Culver City, CA 90232 -2522 |
| Contact | Vivian Lai |
| Correspondent | Vivian Lai DISCUS DENTAL, INC. 8550 HIGUERA ST. Culver City, CA 90232 -2522 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-04 |
| Decision Date | 2004-06-18 |
| Summary: | summary |