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

Unit, Electrosurgical, And Accessories, Dental (EKZ) (6) Scaler, Ultrasonic (ELC) (3) Tester, Pulp (EAT) (1)

Premarket Exempt

No Yes

Clear

Parkell® - 00810000520589 Catalog Number : D576BL

Device Description : Parkell® Autoclavable Handpiece Sheath without logo for Turbo 25/30, TurboSENSOR Parkell® Autoclavable Handpiece Sheath without logo for Turbo 25/30, TurboSENSOR® D560, D590 & D595

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Parkell® - 00810000520619 Catalog Number : D579-G

Device Description : Type-G Cordset for Power Transformer

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Parkell® - 00810000520640 Catalog Number : D595MTAH10

Device Description : Parkell® 110 Volt Auto/Manual Tune Ultrasonic Tooth Scaler with Autoclavable Handpiece

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Digitest™ - 00810000520657 Catalog Number : D640E-JM

Device Description : Digitest™ II Digital Pulptester (Japan)

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EAT

Prescription Use : Yes

Device Count : 1

Sensimatic® - 00810000520695 Catalog Number : D601

Device Description : New Indifferent Plate & Red Cable for Sensimatic® 600SE (Complies with New FDA L New Indifferent Plate & Red Cable for Sensimatic® 600SE (Complies with New FDA Lead Wire Regulations)

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

Sensimatic™ - 00810000520701 Catalog Number : D633

Device Description : Black Handpiece and Cable for Sensimatic® Electrosurge

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

Sensimatic® - 00810000520718 Catalog Number : D633CK

Device Description : Locking Chuck (only) for Sensimatic® Handpiece

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

Sensimatic® - 00810000520725 Catalog Number : D634

Device Description : Indifferent Plate for Sensimatic® Electrosurge

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

Sensimatic® - 00810000520732 Catalog Number : D700SE110

Device Description : D700SE Sensimatic® Electrosurge 110v

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

Sensimatic® - 00810000520749 Catalog Number : D700SE110E

Device Description : D700SE Sensimatic® Electrosurge 110-volt

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

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