The following data is part of a premarket notification filed by Rinn Corp. with the FDA for Uni-bite Dental X-ray Film Holder.
| Device ID | K813378 |
| 510k Number | K813378 |
| Device Name: | UNI-BITE DENTAL X-RAY FILM HOLDER |
| Classification | Holder, Film, X-ray |
| Applicant | RINN CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EGZ |
| CFR Regulation Number | 872.1905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-01 |
| Decision Date | 1982-01-29 |