FDA Device Entity Profile: Dentis Co., Ltd.

Known Identifiers & Locations

FEI Numbers 3007031098, 3010373494, 3033509587, 3036190511

Owner Operator Numbers 10025697

Locations Covered Daegu, KR; Dong-gu Daegu, KR

Registered Establishments (4)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3007031098	DENTIS CO., LTD.	Daegu, KR	Manufacture Medical Device	View Details
3010373494	DENTIS MEDICAL DIVISION	Daegu, KR	Manufacture Medical Device	View Details
3033509587	DENTIS MEDICAL DIVISION	Dong-gu Daegu, KR	Manufacture Medical Device	View Details
3036190511	Dentis Co.,Ltd	Dong-gu Daegu, KR	Manufacture Medical Device	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K241065	ChecQ (AC100)	2025-03-21	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

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