The following data is part of a premarket notification filed by Professional Dental Technologies Therapeutics, Inc with the FDA for Pro-dentec Double-pro Prophylaxis Paste With Fluoide Family Of Devices.
| Device ID | K033449 |
| 510k Number | K033449 |
| Device Name: | PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | PROFESSIONAL DENTAL TECHNOLOGIES THERAPEUTICS, INC 500 WHITE DR. Batesville, AR 72501 |
| Contact | Joann Underwood |
| Correspondent | Joann Underwood PROFESSIONAL DENTAL TECHNOLOGIES THERAPEUTICS, INC 500 WHITE DR. Batesville, AR 72501 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-29 |
| Decision Date | 2004-01-07 |
| Summary: | summary |