The following data is part of a premarket notification filed by Pennwalt Corp. with the FDA for Xr-710.
| Device ID | K800063 |
| 510k Number | K800063 |
| Device Name: | XR-710 |
| Classification | Unit, X-ray, Intraoral |
| Applicant | PENNWALT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EAP |
| CFR Regulation Number | 872.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-11 |
| Decision Date | 1980-03-03 |