The following data is part of a premarket notification filed by Kevin Vu, Dds with the FDA for Plaque Scraper-a Interproximal (between Teeth) Plaque Remover, Model Z01, Z02.
| Device ID | K070127 |
| 510k Number | K070127 |
| Device Name: | PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 |
| Classification | Scaler, Periodontic |
| Applicant | KEVIN VU, DDS 1340 WEST PENNSYLVANIA AVE. San Diego, CA 92103 |
| Contact | Glen Feye |
| Correspondent | Glen Feye KEVIN VU, DDS 1340 WEST PENNSYLVANIA AVE. San Diego, CA 92103 |
| Product Code | EMN |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-16 |
| Decision Date | 2007-03-29 |
| Summary: | summary |