The following data is part of a premarket notification filed by Dentsply International with the FDA for Interproximal Reduction System.
| Device ID | K053368 |
| 510k Number | K053368 |
| Device Name: | INTERPROXIMAL REDUCTION SYSTEM |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | DENTSPLY INTERNATIONAL 221 W. PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL 221 W. PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-05 |
| Decision Date | 2006-03-29 |
| Summary: | summary |