The following data is part of a premarket notification filed by Video Dental Concepts, Inc. with the FDA for Retropan Ccd-twain-usb.
| Device ID | K070535 |
| 510k Number | K070535 |
| Device Name: | RETROPAN CCD-TWAIN-USB |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | VIDEO DENTAL CONCEPTS, INC. 110 E. GRANADA BLVD., STE. 207 Ormond Beach, FL 32175 |
| Contact | Claude Berthoin |
| Correspondent | Claude Berthoin VIDEO DENTAL CONCEPTS, INC. 110 E. GRANADA BLVD., STE. 207 Ormond Beach, FL 32175 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-26 |
| Decision Date | 2007-04-24 |
| Summary: | summary |