MASTERLINK LLC

Address:24654 N. Lake Pleasant Parkway Suite 103,Peoria,AZ,85383,US

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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

System, Image Processing, Radiological (LLZ) (2) System,X-Ray,Extraoral Source,Digital (MUH) (2)

Premarket Exempt

Clear

Apex Capture Software - D875400101 Catalog Number :

Device Description : Dental imaging capture, enhance and display software.

Device Class : 2

Duns Number: 017009932

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Apex Cloud Software - D875403051 Catalog Number :

Device Description : A cloud-based, PACS-server software application that gives dental organizations A cloud-based, PACS-server software application that gives dental organizations web access to patient images that have been captured from any DICOM-enabled device.

Device Class : 2

Duns Number: 017009932

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Apex - D875S11684127104 Catalog Number :

Device Description : Size #1 Pedo Dental X-Ray Sensor for radiographic examination and diagnosis of d Size #1 Pedo Dental X-Ray Sensor for radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure.

Device Class : 2

Duns Number: 017009932

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Apex - D875S11685127105 Catalog Number :

Device Description : Size #2 Adult Dental X-Ray Sensor for radiographic examination and diagnosis of Size #2 Adult Dental X-Ray Sensor for radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure.

Device Class : 2

Duns Number: 017009932

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

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