The following data is part of a premarket notification filed by Benn Research Ltd. with the FDA for Repositionable Bitewing X-ray Film Holder Kit.
| Device ID | K891186 |
| 510k Number | K891186 |
| Device Name: | REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT |
| Classification | Aligner, Beam, X-ray |
| Applicant | BENN RESEARCH LTD. 2 PANGBOURNE DR. Stanmore, Middlesex, GB Ha7 4qt |
| Contact | Douglas K Benn |
| Correspondent | Douglas K Benn BENN RESEARCH LTD. 2 PANGBOURNE DR. Stanmore, Middlesex, GB Ha7 4qt |
| Product Code | EHA |
| CFR Regulation Number | 872.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-06 |
| Decision Date | 1989-04-12 |