The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Heliodent Vario.
| Device ID | K000672 |
| 510k Number | K000672 |
| Device Name: | HELIODENT VARIO |
| Classification | Unit, X-ray, Extraoral With Timer |
| 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 | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-28 |
| Decision Date | 2000-05-02 |