The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Teneo Dental Treatment Unit And Accessories.
| Device ID | K151045 |
| 510k Number | K151045 |
| Device Name: | TENEO Dental Treatment Unit And Accessories |
| Classification | Unit, Operative Dental |
| Applicant | SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim, DE 64625 |
| Contact | Thomas Diesch |
| Correspondent | Kofi Aninakwa SIRONA DENTAL SYSTEMS, INC. 30-30 47TH AVENUE, SUITE 500 Long Island City, NY 11101 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-20 |
| Decision Date | 2015-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E27641760170 | K151045 | 000 |