The following data is part of a premarket notification filed by Gendex Corp. with the FDA for Oralix Dc.
| Device ID | K931001 |
| 510k Number | K931001 |
| Device Name: | ORALIX DC |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | GENDEX CORP. 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Contact | Robert E Ueberfluss |
| Correspondent | Robert E Ueberfluss GENDEX CORP. 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-26 |
| Decision Date | 1993-09-14 |