Instarisa Technologies, LLC

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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

Material, Impression (ELW) (1)

Premarket Exempt

Clear

ScanDAR - D989SD11 Catalog Number :

Device Description : Addition-curing silicone for Scanning Detection And bite Registration, extra har Addition-curing silicone for Scanning Detection And bite Registration, extra hard, fast drying

Device Class : 2

Duns Number: 101879683

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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