The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Dental X-ray Unit Heliodent 70.
| Device ID | K781288 |
| 510k Number | K781288 |
| Device Name: | DENTAL X-RAY UNIT HELIODENT 70 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | SIEMENS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-26 |
| Decision Date | 1978-09-11 |