Dentium Co., Ltd

Address:76, Changnyong-daero 256beon-gil, Yeongtong-gu,Suwon-si Gyeonggi,KR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

X-Ray, Tomography, Computed, Dental (OAS) (3) Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (2) System, X-Ray, Extraoral Source, Digital (MUH) (2) Controller, Foot, Handpiece And Cord (EBW) (1)

Premarket Exempt

Clear

bright MCT - 08809460309836 Catalog Number :

Device Class : 2

Duns Number: 695504638

Premarket Exempt : No

Product Code : OAS

Prescription Use : No

Device Count : 1

iCTmotor - 08809460309843 Catalog Number : WL-1

Device Description : As an electric drive motor used in the implant surgery by a dental specialist, t As an electric drive motor used in the implant surgery by a dental specialist, the iCTmotor is an instrument tool used in cutting pubic bone, setting an implant or abutment when it combines to a hand-piece in which includes a medical drill, and also has the functions necessary to combine with other devices. The motor was designed as being able to control rotational speed (RPM) and torque, and to select variable options and/or cooling water-supply according to surgery steps. The motor has various ratios in the final value of rotational speed and torque, according to a mechanical reduction gear ratio.

Device Class : 1

Duns Number: 695504638

Premarket Exempt : No

Product Code : EBW

Prescription Use : No

Device Count : 1

Intra Oral Sensor - 08809460309850 Catalog Number : IOX1

Device Description : Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digit Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays.

Device Class : 2

Duns Number: 695504638

Premarket Exempt : No

Product Code : MQB, MUH

Prescription Use : No

Device Count : 1

Intra Oral Sensor - 08809460309867 Catalog Number : IOX2

Device Class : 2

Duns Number: 695504638

Premarket Exempt : No

Product Code : MQB, MUH

Prescription Use : No

Device Count : 1

rainbow CT - 08809544906340 Catalog Number :

Device Class : 2

Duns Number: 695504638

Premarket Exempt : No

Product Code : OAS

Prescription Use : No

Device Count : 1

rainbow CT - 08809544906357 Catalog Number :

Device Class : 2

Duns Number: 695504638

Premarket Exempt : No

Product Code : OAS

Prescription Use : No

Device Count : 1

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