The following data is part of a premarket notification filed by Den-tal-ez Mfg Co., Inc. with the FDA for Panoramic X-ray, Dental.
| Device ID | K780469 |
| 510k Number | K780469 |
| Device Name: | PANORAMIC X-RAY, DENTAL |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | DEN-TAL-EZ MFG CO., INC. 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 | 1978-03-22 |
| Decision Date | 1978-04-10 |