The following data is part of a premarket notification filed by Dentron Systems Llc with the FDA for Dentron Sensor.
| Device ID | K080738 |
| 510k Number | K080738 |
| Device Name: | DENTRON SENSOR |
| Classification | Unit, X-ray, Intraoral |
| Applicant | DENTRON SYSTEMS LLC 11 EAST GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Contact | Claude D Berthoin |
| Correspondent | Claude D Berthoin DENTRON SYSTEMS LLC 11 EAST GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Product Code | EAP |
| CFR Regulation Number | 872.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-17 |
| Decision Date | 2008-05-13 |
| Summary: | summary |