The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Gendex 765dc, Model 110-0154.
| Device ID | K992610 |
| 510k Number | K992610 |
| Device Name: | GENDEX 765DC, MODEL 110-0154 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | DENTSPLY INTL. 901 WEST OAKTON ST. Des Plaines, IL 60018 -1884 |
| Contact | Daniel P Murphy |
| Correspondent | Daniel P Murphy DENTSPLY INTL. 901 WEST OAKTON ST. Des Plaines, IL 60018 -1884 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-04 |
| Decision Date | 1999-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV100625810 | K992610 | 000 |
| EKAV082252140 | K992610 | 000 |
| EKAV082252120 | K992610 | 000 |