The following data is part of a premarket notification filed by Mti Precision Products with the FDA for Lynx Low-speed Handpiece.
| Device ID | K940261 |
| 510k Number | K940261 |
| Device Name: | LYNX LOW-SPEED HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | MTI PRECISION PRODUCTS P.O. BOX 221 175 OBERLIN N. AVE. Lakewood, NJ 08701 |
| Contact | Mike Feldman |
| Correspondent | Mike 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 | 1994-01-21 |
| Decision Date | 1994-12-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D826LX100B40 | K940261 | 000 |
| D82650250030 | K940261 | 000 |
| D82650250060 | K940261 | 000 |
| D82650250080 | K940261 | 000 |
| D826LX101040 | K940261 | 000 |
| D826LX11SNCL030 | K940261 | 000 |
| D826LX11SNCS030 | K940261 | 000 |
| D826LX14SNCL040 | K940261 | 000 |
| D826LXTM520 | K940261 | 000 |
| D826LXTM540 | K940261 | 000 |
| D82650136040 | K940261 | 000 |