dexcowin.comCocoon Portable Handheld X-Ray System
Dexcowin Co., Ltd.
DEXCOWIN CO., LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007065358 | 3007065358 | DEXCOWIN CO., LTD. | 1 | N | 2027-01-01 | 901-905, 25, Gasan digital 1-ro Geumcheon-gu Seoul KR 08594 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 08800000500003 | DX3000; iRay; iRay D3 - Portable x-ray system indicated for taking diagnostic dental x-rays for both pediatric and adult patients using intraoral film or digital sensors. | 626-993-6716 | info@dexcowin.com |
| 08800000500010 | ADX4000; iRay D4 - Portable x-ray system intended for dental radio-graphic examination and diagnosis of diseases of the teeth, jaw and oral structure for both pediatric and adult patients. | 626-993-6716 | info@dexcowin.com |
| 08800000500027 | ADX6000; iRay A6 - Portable x-ray system intended for dental radio-graphic examination and diagnosis of diseases of the teeth, jaw and oral structure for both pediatric and adult patients. | 626-993-6716 | info@dexcowin.com |
| 08800000500041 | Rex 2 - Intended for dental radio-graphic examination and diagnosis of diseases of the teeth, jaw and oral structure. | 626-993-6716 | info@dexcowin.com |
| 08800000500058 | Cocoon - Portable x-ray system indicated for taking diagnostic dental x-rays for both pediatric and adult patients using intraoral film or PSP or digital sensors. | 626-993-6600 | info@dexcowin.com |
| 08800000500065 | Cocoon - Portable x-ray system indicated for taking diagnostic dental x-ray for both pediatric and adult patients using intraoral film or PSP or digital sensors. | 626-993-6600 | info@dexcowin.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 149235 | 1988251054 | K250687 | Cocoon Solo (DX-7020s) | MUH | 2025-10-24 |
| 149235 | 1774690400 | K173046 | Cocoon Portable Handheld X-Ray System | MUH | 2017-10-26 |
| 149235 | 2065742046 | K143494 | ADX6000 Portable X-Ray System; iRayA6 | IZL | 2015-10-05 |
| 149235 | 1848934447 | K140060 | DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A | MQB | 2014-05-13 |
| 149235 | 1827872708 | K134055 | ADX4000W | MUH | 2014-05-09 |
| 149235 | 1636538386 | K133007 | DX3000-L | MUH | 2014-04-24 |
| 149235 | 1069454816 | K083532 | ADX4000-L, DX3000-L | MUH | 2009-03-10 |
| 149235 | 1019996825 | K070811 | CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000 | MUH | 2007-07-05 |
| 149235 | 1100882599 | ||||
| 149235 | 1120485004 | ||||
| 149235 | 1158907443 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Cocoon Solo - Portable x-ray system indicated for taking diagnostic dental x-ray for both pediatric and adult patients using intraoral film or PSP or digital sensors.
2026-03-31
DX3000; iRay; iRay D3 - Portable x-ray system indicated for taking diagnostic dental x-rays for both pediatric and adult patients using intraoral film or digital sensors.
2017-02-28
ADX4000; iRay D4 - Portable x-ray system intended for dental radio-graphic examination and diagnosis of diseases of the teeth, jaw and oral structure for both pediatric and adult patients.
2017-02-28
Rex 2 - Intended for dental radio-graphic examination and diagnosis of diseases of the teeth, jaw and oral structure.
2017-02-28
ADX6000; iRay A6 - Portable x-ray system intended for dental radio-graphic examination and diagnosis of diseases of the teeth, jaw and oral structure for both pediatric and adult patients.
2017-02-28
Cocoon - Portable x-ray system indicated for taking diagnostic dental x-rays for both pediatric and adult patients using intraoral film or PSP or digital sensors.
2017-12-13
Cocoon - Portable x-ray system indicated for taking diagnostic dental x-ray for both pediatric and adult patients using intraoral film or PSP or digital sensors.
2017-12-13