The following data is part of a premarket notification filed by Bite-a-block with the FDA for Dental X-ray Bite Block.
| Device ID | K890355 |
| 510k Number | K890355 |
| Device Name: | DENTAL X-RAY BITE BLOCK |
| Classification | Holder, Film, X-ray |
| Applicant | BITE-A-BLOCK P.O. BOX 810 Daly City, CA 94017 |
| Contact | Nancy T Pua |
| Correspondent | Nancy T Pua BITE-A-BLOCK P.O. BOX 810 Daly City, CA 94017 |
| Product Code | EGZ |
| CFR Regulation Number | 872.1905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-24 |
| Decision Date | 1989-06-12 |