The following data is part of a premarket notification filed by Kaltenbach & Voigt Gmbh with the FDA for Mastermatic Lux.
| Device ID | K143465 |
| 510k Number | K143465 |
| Device Name: | MASTERmatic LUX |
| Classification | Handpiece, Belt And/or Gear Driven, Dental |
| Applicant | Kaltenbach & Voigt Gmbh Bismarckring 39 Biberach, DE 88400 |
| Contact | Stefan Trampler |
| Correspondent | Stefan Trampler Kaltenbach & Voigt Gmbh Bismarckring 39 Biberach, DE 88400 |
| Product Code | EFA |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-04 |
| Decision Date | 2015-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV100936400 | K143465 | 000 |
| 10194665004460 | K143465 | 000 |
| 10194665004521 | K143465 | 000 |
| 10194665004538 | K143465 | 000 |
| EKAV100935700 | K143465 | 000 |
| EKAV100935800 | K143465 | 000 |
| EKAV100936100 | K143465 | 000 |
| EKAV100936200 | K143465 | 000 |
| EKAV100936300 | K143465 | 000 |
| 10194665005528 | K143465 | 000 |