3D IMAGING AND SIMULATION CORP. AMERICAS

Address:365 Herndon Pkwy,Herndon,VA,20170,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, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations (NOF) (1)

Premarket Exempt

Yes

Clear

Heron IOS - 00864206000406 Catalog Number :

Device Description : Heron IOS system is an optical impression system used to record the topographic Heron IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Heron IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.

Device Class : 2

Duns Number: 117033482

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

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