The following data is part of a premarket notification filed by Chicago X-ray Systems, Inc. with the FDA for Flash Dent.
| Device ID | K931300 |
| 510k Number | K931300 |
| Device Name: | FLASH DENT |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | CHICAGO X-RAY SYSTEMS, INC. 219 MAYER AVE. Wheeling, IL 60090 |
| Contact | Al Sosa |
| Correspondent | Al Sosa CHICAGO X-RAY SYSTEMS, INC. 219 MAYER AVE. Wheeling, IL 60090 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-15 |
| Decision Date | 1994-03-21 |