DPM USA CORP

Address:1460 N.W. 107TH AVE., STE. G,Doral,FL,33172,US

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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

Unit, X-Ray, Extraoral With Timer (EHD) (2)

Premarket Exempt

Clear

Bi Image X-Evolution Wall - 10850786008014 Catalog Number : PC17B

Device Description : An extraoral source x-ray system is an AC-powered device that produces x-rays an An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Device Class : 2

Duns Number: 007087206

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

Bi-Image-X Evolution Mobile - 10850786008021 Catalog Number : PC17B

Device Description : An extra-oral source x-ray system is an AC-powered device that produces x-rays a An extra-oral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.