The following data is part of a premarket notification filed by Dentalez Group with the FDA for Portable Hdx Intraoral X-ray.
| Device ID | K021378 |
| 510k Number | K021378 |
| Device Name: | PORTABLE HDX INTRAORAL X-RAY |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | DENTALEZ GROUP 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Contact | Deon Beck |
| Correspondent | Deon Beck DENTALEZ GROUP 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-01 |
| Decision Date | 2002-06-07 |
| Summary: | summary |