GENDEX 765DC, MODEL 110-0154
FDA 510(k) clearance K992610 · decided 1999-09-07
Clearance details
- K-number
- K992610
- Device name
- GENDEX 765DC, MODEL 110-0154
- Applicant
- Dentsply Intl.
- Decision
- Substantially Equivalent
- Date received
- 1999-08-04
- Decision date
- 1999-09-07
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- EHD
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Des Plaines, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dentsply Intl.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Portable Dental X-ray System Model PDX nova (K260367) | PDX Co., Ltd. | 2026-05-27 |
| NOMAD Pro 3 (K253864) | Dental Imaging Technologies Corporation | 2026-03-20 |
| Dental X-RAY Unit (AJX200) (K252110) | Guangzhou Ajax Medical Equipment Co., Ltd. | 2026-03-12 |
| Portable Dental X-ray Device (GT-1) (K254018) | Guilin Refine Medical Instrument Co., Ltd. | 2026-02-19 |
| Diagnostic X-Ray Equipment Model POCT22 (K252909) | Ningbo Runyes Medical Instrument Co., Ltd. | 2026-02-03 |
| Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (K251438) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2025-09-04 |
| Rextar Pro (K242185) | Raypia Co., Ltd. | 2024-12-04 |
| XERO-alpha (K242591) | DRTECH Corporation | 2024-11-01 |
| WERAY (K241963) | Picopack Co., Ltd. | 2024-07-30 |
| LifeRay Intraoral Handheld X-ray System (K241305) | Lucas Lifecare | 2024-07-05 |
| REMEX-GR100 (K240759) | Remedi Co., Ltd. | 2024-05-13 |
| XVbeam2000 (K233914) | Shenzhen Xpectvision Technology Co., Ltd. | 2024-02-08 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch rea recall (Z-0009-2015) | Gendex Corp | 2014-10-02 |
| Gendex eXpert DC Intraoral Dental X-Ray System Device is to be used as an extra-oral sourc recall (Z-1358-2012) | Gendex Dental Systems | 2012-04-02 |
| Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF recall (Z-1559-2011) | Gendex Dental Systems | 2011-03-04 |
| Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Mod recall (Z-1248-2011) | Gendex Dental Systems | 2011-02-15 |