The following data is part of a premarket notification filed by Handpiece Unlimited with the FDA for Mk-dent Push Button Highspeed Handpiece, 4 Holes, Models Hs 2012 (standard Head) & Hs 2014 (small Head).
| Device ID | K021250 |
| 510k Number | K021250 |
| Device Name: | MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) |
| Classification | Material, Tooth Shade, Resin |
| Applicant | HANDPIECE UNLIMITED KATHARINENSTR. 5 Lubeck, DE 23554 |
| Contact | Martina Gunderoth |
| Correspondent | Martina Gunderoth HANDPIECE UNLIMITED KATHARINENSTR. 5 Lubeck, DE 23554 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-19 |
| Decision Date | 2002-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050546001470 | K021250 | 000 |
| 04050546001265 | K021250 | 000 |
| 04050546001272 | K021250 | 000 |
| 04050546001289 | K021250 | 000 |
| 04050546001418 | K021250 | 000 |
| 04050546001425 | K021250 | 000 |
| 04050546001432 | K021250 | 000 |
| 04050546001449 | K021250 | 000 |
| 04050546001456 | K021250 | 000 |
| 04050546001463 | K021250 | 000 |
| 04050546001258 | K021250 | 000 |