The following data is part of a premarket notification filed by Preventive Technologies, Inc. with the FDA for Preventech Prophylaxis Paste With Fluoride.
| Device ID | K100539 |
| 510k Number | K100539 |
| Device Name: | PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | PREVENTIVE TECHNOLOGIES, INC. 4330 MATHEWS-INDIAN TRAIL ROAD Indian Trial, NC 28079 |
| Contact | Kenneth S Peterson |
| Correspondent | Kenneth S Peterson PREVENTIVE TECHNOLOGIES, INC. 4330 MATHEWS-INDIAN TRAIL ROAD Indian Trial, NC 28079 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-25 |
| Decision Date | 2010-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D02411000633 | K100539 | 000 |
| D0242200833 | K100539 | 000 |
| D0242200933 | K100539 | 000 |
| D0242201033 | K100539 | 000 |
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| D0242203733 | K100539 | 000 |
| D0242203933 | K100539 | 000 |
| D0242204033 | K100539 | 000 |
| D0244403633 | K100539 | 000 |