The following data is part of a premarket notification filed by Mti Precision Products with the FDA for Lynx-sm, Sclaer Dental Handpiece.
| Device ID | K901488 |
| 510k Number | K901488 |
| Device Name: | LYNX-SM, SCLAER DENTAL HANDPIECE |
| Classification | Scaler, Ultrasonic |
| 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 | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-29 |
| Decision Date | 1990-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D826LX3004H090 | K901488 | 000 |
| D826LX3004H040 | K901488 | 000 |
| D826LX3004H031 | K901488 | 000 |
| D826LX3004H021 | K901488 | 000 |
| D826LX3002H090 | K901488 | 000 |
| D826LX3002H040 | K901488 | 000 |
| D826LX3002H031 | K901488 | 000 |
| D826LX3002H021 | K901488 | 000 |