The following data is part of a premarket notification filed by Denterprise International, Inc. with the FDA for Quickray Hd Intraoral Sensor.
| Device ID | K151926 |
| 510k Number | K151926 |
| Device Name: | QuickRay HD Intraoral Sensor |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | DENTERPRISE INTERNATIONAL, INC. 100 EAST GRANADA BLVD SUITE 219 Ormond Beach, FL 32176 |
| Contact | Claude Berthoin |
| Correspondent | Claude Berthoin DENTERPRISE INTERNATIONAL, INC. 100 EAST GRANADA BLVD SUITE 219 Ormond Beach, FL 32176 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-14 |
| Decision Date | 2015-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858475006054 | K151926 | 000 |
| 00858475006047 | K151926 | 000 |
| 00858475006023 | K151926 | 000 |
| 00858475006016 | K151926 | 000 |
| 00858475006184 | K151926 | 000 |
| 00858475006177 | K151926 | 000 |