VATECH CO., LTD.

Address:13, Samsung 1-ro, 2-gil,Hwaseong-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) (6)

Premarket Exempt

Clear

Green X 18 - 08800016400793 Catalog Number :

Device Description : Dental Computed Tomography X-ray System functioning Pano/CT/CEPH Image Acquisiti Dental Computed Tomography X-ray System functioning Pano/CT/CEPH Image Acquisition Xmaru1524CF Master Plus OP, Xmaru2602CF/W-Ceph(P)/MASTER

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

vatech A9 - 08800016401097 Catalog Number :

Device Description : Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition Xm Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition Xmaru1404CF-Plus

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

vatech A9 - 08800016401103 Catalog Number :

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

Smart Plus - 08800016401301 Catalog Number :

Device Description : Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

Smart Plus - 08800016401318 Catalog Number :

Device Description : Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Imag Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

Smart Plus - 08800016401325 Catalog Number :

Device Description : Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (X Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1404CF)

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

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