The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Sirona C8 Dental Operative Unit With Accessories.
| Device ID | K983242 |
| 510k Number | K983242 |
| Device Name: | SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES |
| Classification | Unit, Operative Dental |
| Applicant | SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Sheila Hameon-heyer |
| Correspondent | Sheila Hameon-heyer SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-16 |
| Decision Date | 1998-12-11 |
| Summary: | summary |