The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Heliodent Plus.
| Device ID | K083344 |
| 510k Number | K083344 |
| Device Name: | HELIODENT PLUS |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim, DE D-64625 |
| Contact | Fritz Kolle |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-11-13 |
| Decision Date | 2008-12-23 |
| Summary: | summary |