Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029916103

FEI Number

3029916103

Entity Name

PICOPACK Inc.

City/State/Country

Daejeon, KR

Establishment Address

Rm.201, 101, 102, 105, 106, 91, Sinilseo-ro 85beon-gil, Daedeok-gu, Daejeon 34325, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PICOPACK Inc. (Owner Number: 10088890)

Owner / Operator Contact Address

Rm.201, 101, 102, 105, 106, 91, Sinilseo-ro 85beon-gil, Daedeok-gu, Daejeon, KR-30 34325, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230916

PMA Number

N/A

All Registered Proprietary Names

WeRay MDP WeSensor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2024-08-20
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2023-10-18

Official Correspondent

Dong-Il Kim

US Agent Details

Edward Park Business: Lighten Bridge LLC Email: lightenbridge@gmail.com Phone: (972) 8000044

Related Public Records

Same Entity

PICOPACK Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

Similar Registrations

Registration Number	Establishment Name	Location
3005581016	GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD	GUILIN CITY Guangxi, CN
3007933232	DIGIMED CO., LTD	Seoul, KR
3003528079	XLINE SRL	ASSAGO Milano, IT
3002994636	DE GOTZEN S.R.L.	FAGNANO OLONA Varese, IT
3008770655	BEYES DENTAL INC	Toronto Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029916103. Last updated year: 2026. Please use registration number 3029916103 when referencing this establishment in official correspondence.