The following data is part of a premarket notification filed by Mti Precision Products with the FDA for Master Classic 5k Low Speed Handpiece, 20k Low Speed Handpiece, Tm5 Low Speed Handpiece And Tm20 Low Speed Handpiece.
| Device ID | K070001 |
| 510k Number | K070001 |
| Device Name: | MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | MTI PRECISION PRODUCTS 175 OBERLIN AVE., NORTH Lakewood, NJ 08701 |
| Contact | Tod Brenner |
| Correspondent | Tod Brenner MTI PRECISION PRODUCTS 175 OBERLIN AVE., NORTH Lakewood, NJ 08701 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-03 |
| Decision Date | 2007-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D950105400 | K070001 | 000 |
| D82650135030 | K070001 | 000 |
| D82650154030 | K070001 | 000 |
| D82650154060 | K070001 | 000 |
| D82650154080 | K070001 | 000 |
| D82650163040 | K070001 | 000 |
| D826LXPRO540 | K070001 | 000 |
| D950105300 | K070001 | 000 |
| D950105310 | K070001 | 000 |
| D950105320 | K070001 | 000 |
| D950105330 | K070001 | 000 |
| D950105350 | K070001 | 000 |
| D950105360 | K070001 | 000 |
| D950105370 | K070001 | 000 |
| D950105380 | K070001 | 000 |
| D9501053900 | K070001 | 000 |
| D950105390 | K070001 | 000 |