The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Orthophos 5/plus/cd.
| Device ID | K983057 |
| 510k Number | K983057 |
| Device Name: | ORTHOPHOS 5/PLUS/CD |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Sheila M Hemeon-heyer |
| Correspondent | Sheila M 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 | 1998-09-01 |
| Decision Date | 1998-10-22 |