The following data is part of a premarket notification filed by Kaltenbach & Voigt Gmbh with the FDA for Mastertorque Lux 8900 L.
| Device ID | K130560 |
| 510k Number | K130560 |
| Device Name: | MASTERTORQUE LUX 8900 L |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | KALTENBACH & VOIGT GMBH BISMARCKRING 39 Biberach / Riss, DE 88400 |
| Contact | Stefan Trampler |
| Correspondent | Stefan Trampler KALTENBACH & VOIGT GMBH BISMARCKRING 39 Biberach / Riss, DE 88400 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-04 |
| Decision Date | 2013-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV101123300 | K130560 | 000 |
| EKAV100878000 | K130560 | 000 |
| EKAV100717000 | K130560 | 000 |
| 10194665004484 | K130560 | 000 |
| 10194665004477 | K130560 | 000 |