The following data is part of a premarket notification filed by Dentamerica with the FDA for Digirex Digital Dental Radiography System.
| Device ID | K060640 |
| 510k Number | K060640 |
| Device Name: | DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | DENTAMERICA 18320 BEDFORD CIRCLE P.O. BOX 3200 Industry, CA 91744 |
| Contact | Eric Huang |
| Correspondent | Eric Huang DENTAMERICA 18320 BEDFORD CIRCLE P.O. BOX 3200 Industry, CA 91744 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-10 |
| Decision Date | 2006-04-24 |
| Summary: | summary |