The following data is part of a premarket notification filed by Kaltenbach & Voigt Gmbh with the FDA for Prophyflex 4.
| Device ID | K181110 |
| 510k Number | K181110 |
| Device Name: | PROPHYflex 4 |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | Kaltenbach & Voigt GmbH Bismarckring 39 Biberach, DE 88400 |
| Contact | Stefan Trampler |
| Correspondent | Frank Ray KaVo Dental Technologies, LLC 11727 Fruehauf Drive Charlotte, NC 28273 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-27 |
| Decision Date | 2019-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV300459000 | K181110 | 000 |
| EKAV300288000 | K181110 | 000 |
| EKAV300282000 | K181110 | 000 |
| EKAV300280000 | K181110 | 000 |
| EKAV101002870 | K181110 | 000 |