The following data is part of a premarket notification filed by Mti Precision Products with the FDA for Lynx-high Speed Handpiece.
| Device ID | K895736 |
| 510k Number | K895736 |
| Device Name: | LYNX-HIGH SPEED HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | MTI PRECISION PRODUCTS P.O. BOX 221 175 OBERLIN N. AVE. Lakewood, NJ 08701 |
| Contact | Michael Feldman |
| Correspondent | Michael Feldman MTI PRECISION PRODUCTS P.O. BOX 221 175 OBERLIN N. AVE. Lakewood, NJ 08701 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-26 |
| Decision Date | 1989-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D826TM2040 | K895736 | 000 |
| D826TM2020 | K895736 | 000 |
| D826LX100B20 | K895736 | 000 |
| D82650087030 | K895736 | 000 |
| D82650077030 | K895736 | 000 |