The following data is part of a premarket notification filed by G & A Industries, Inc. with the FDA for Xenex Dental Roulette.
| Device ID | K880485 |
| 510k Number | K880485 |
| Device Name: | XENEX DENTAL ROULETTE |
| Classification | Toothbrush, Manual |
| Applicant | G & A INDUSTRIES, INC. 60 RICE RUN East Brunswick, NJ 08816 |
| Contact | Gil Shapira |
| Correspondent | Gil Shapira G & A INDUSTRIES, INC. 60 RICE RUN East Brunswick, NJ 08816 |
| Product Code | EFW |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-04 |
| Decision Date | 1988-05-02 |