The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Orthophos 3/3 Ceph/3 Ds.
| Device ID | K990528 |
| 510k Number | K990528 |
| Device Name: | ORTHOPHOS 3/3 CEPH/3 DS |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Sheila Hemeon-heyer |
| Correspondent | Sheila Hemeon-heyer SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-19 |
| Decision Date | 1999-04-30 |