PARKELL, INC.

Address:300 EXECUTIVE DR.,EDGEWOOD,NY,11717,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

Resin, Denture, Relining, Repairing, Rebasing (EBI) (2) Material, Impression (ELW) (1)

Premarket Exempt

No Yes

Clear

SHARP™ - M595S5120 Catalog Number : S512

Device Description : SHARP™ Heavy-Body Premium Hydrophilic VPS Impression Material

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

NA - M595S8150 Catalog Number : S815

Device Description : 500ml Bottle of Bonding Liner for Acrylic Solder

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

NA - M595S8260 Catalog Number : S826

Device Description : OTC Primer 1.5ml Bottle

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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