The following data is part of a premarket notification filed by Mtc Industries And Research, Ltd. with the FDA for Mtc 7707 High Speed Air Turbine.
| Device ID | K945256 |
| 510k Number | K945256 |
| Device Name: | MTC 7707 HIGH SPEED AIR TURBINE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | MTC INDUSTRIES AND RESEARCH, LTD. P.O. BOX 232 1 MAGAL ST. CARMIEL IND. EST. Carmiel, IL 20100 |
| Contact | V Shribman |
| Correspondent | V Shribman MTC INDUSTRIES AND RESEARCH, LTD. P.O. BOX 232 1 MAGAL ST. CARMIEL IND. EST. Carmiel, IL 20100 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-28 |
| Decision Date | 1996-01-29 |