The following data is part of a premarket notification filed by Promident Mfg., Ltd. with the FDA for Air Powered Dental Handpiece.
| Device ID | K781545 |
| 510k Number | K781545 |
| Device Name: | AIR POWERED DENTAL HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | PROMIDENT MFG., LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-12 |
| Decision Date | 1978-11-15 |