The following data is part of a premarket notification filed by Micro Motors, Inc. with the FDA for 29540 Dynasurg Electric Handpiece And Irr. System.
| Device ID | K911068 |
| 510k Number | K911068 |
| Device Name: | 29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | MICRO MOTORS, INC. 151 EAST COLUMBINE AVE. Santa Ana, CA 92707 |
| Contact | Russ Reinsch |
| Correspondent | Russ Reinsch MICRO MOTORS, INC. 151 EAST COLUMBINE AVE. Santa Ana, CA 92707 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-11 |
| Decision Date | 1991-05-15 |