Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022396768

FEI Number

3022396768

Entity Name

DUNAMIS DENTAL CO., LTD.

City/State/Country

Gwangmyeong-si Gyeonggi, KR

Establishment Address

904, A-Dong, Gwangmyeong Technopark, Haan-Ro 60, Gwangmyeong-Si, Gyeonggi-Do, Republic of Korea, 14322, Gwangmyeong-si Gyeonggi 14322, KR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

DUNAMIS DENTAL Co., Ltd. (Owner Number: 10084538)

Owner / Operator Contact Address

904, A-Dong, Gwangmyeong Technopark, Haan-Ro 60, Gwangmyeong-Si, Gyeonggi-Do, Republic of Korea, 14322, Gwangmyeong-si, KR-NOTA 14322, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Karam-STR Karam-ANG KT15-45SQD KT15-SLK Karam-Delix KT15-45SLN KT15-SQD KT15-45ECN S M4 Karam-AM KT15-ECN S B2 KT15-45SN KT15-45SLK KT15-ECN S M4 Karam-Lab KT15-SK KT15-SN KT15-45SK KT15-45ECN S B2 KT15-SLN SAM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2022-03-23
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2022-03-23

Official Correspondent

Yang Soo Kim

US Agent Details

Wonpyo Hong Business: Wonpyo Hong Email: dean.baek@comvalis-usagent.com Phone: (415) 9809460

Related Public Records

Same Entity

DUNAMIS DENTAL Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022396768. Last updated year: 2026. Please use registration number 3022396768 when referencing this establishment in official correspondence.