The following data is part of a premarket notification filed by Kaltenbach & Voigt Gmbh with the FDA for Estetica Dental Treatment Unit And Accessories.
| Device ID | K161488 |
| 510k Number | K161488 |
| Device Name: | ESTETICA Dental Treatment Unit And Accessories |
| Classification | Unit, Operative 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 | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-01 |
| Decision Date | 2016-12-08 |
| Summary: | summary |