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

Locator, Root Apex (LQY) (5) Scaler, Ultrasonic (ELC) (3) Activator, Ultraviolet, For Polymerization (EBZ) (2)

Premarket Exempt

No Yes

Clear

Parkell® - 00810000520176 Catalog Number : D555

Device Description : Replacement Battery for Parkell® D553 Curing Light

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

Parkell® - 00810000520183 Catalog Number : D556

Device Description : Charging Stand for Parkell® D553 Curing Light

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

Foramatron® - 00810000520220 Catalog Number : D611

Device Description : Touch-Proof Wire Assembly for Model D-10 Foramatron® (Includes: Lip Clips, Quick Touch-Proof Wire Assembly for Model D-10 Foramatron® (Includes: Lip Clips, Quick Test Probe Reamer Holder & Touch-Proof Wire)

Device Class : U

Duns Number: 009900424

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

Foramatron® - 00810000520237 Catalog Number : D613

Device Description : Quick Probe for Foramatron® All Models

Device Class : U

Duns Number: 009900424

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

Foramatron® - 00810000520251 Catalog Number : D619RH

Device Description : Universal Reamer Holder for Foramatron® All Models

Device Class : U

Duns Number: 009900424

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

Foramatron® - 00810000520268 Catalog Number : D619WAE

Device Description : Wire Assembly with 2-Ground Clips for Foramatron® IV D610E E

Device Class : U

Duns Number: 009900424

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

Foramatron® - 00810000520275 Catalog Number : D645

Device Description : The Foramatron® Electronic Apex Locator

Device Class : U

Duns Number: 009900424

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

Integra™ - 00810000520299 Catalog Number : D680110

Device Description : 110v Integra™ Ultrasonic Scaling System

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Integra™ - 00810000520305 Catalog Number : D680-230

Device Description : 230-volt Integra™ Ultrasonic Scaling System

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

PerioSonic® - 00810000520336 Catalog Number : D583

Device Description : PerioSonic® Multi-Fluid Irrigator Basic

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

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