The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Rapidd Highspeed Dental Handpiece.
| Device ID | K003518 |
| 510k Number | K003518 |
| Device Name: | RAPIDD HIGHSPEED DENTAL HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Contact | P. Jeffrey Lehn |
| Correspondent | P. Jeffrey Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-15 |
| Decision Date | 2001-01-09 |