The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Orthophos Sl.
| Device ID | K150217 |
| 510k Number | K150217 |
| Device Name: | ORTHOPHOS SL |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | Sirona Dental Systems GMBH Fabrikstrasse 31 Bensheim, DE 64623 |
| Contact | Thomas Diesch |
| Correspondent | Kofi Aninakwa SIRONA DENTAL SYSTEMS, INC. 30-30 47TH AVENUE SUITE 500 Long Island, NY 11101 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-30 |
| Decision Date | 2015-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E27664731230 | K150217 | 000 |
| E27664664400 | K150217 | 000 |
| E27664649990 | K150217 | 000 |