The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Dendia Werk Burs And Cutting Discs.
| Device ID | K901967 |
| 510k Number | K901967 |
| Device Name: | DENDIA WERK BURS AND CUTTING DISCS |
| Classification | Instrument, Diamond, Dental |
| Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Contact | Len Leritz |
| Correspondent | Len Leritz MICRO-AIRE SURGICAL INSTRUMENTS, INC. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Product Code | DZP |
| CFR Regulation Number | 872.4535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-01 |
| Decision Date | 1990-07-13 |