The following data is part of a premarket notification filed by Dexco with the FDA for Cordless Portable Dental X-ray System, Model Adx4000.
| Device ID | K070811 |
| 510k Number | K070811 |
| Device Name: | CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000 |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | DEXCO 11 DELLCASTLE COURT Montgomery Village, MD 20886 |
| Contact | Robert Mazzaferro |
| Correspondent | Robert Mazzaferro DEXCO 11 DELLCASTLE COURT Montgomery Village, MD 20886 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-26 |
| Decision Date | 2007-07-05 |
| Summary: | summary |