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

Scaler, Ultrasonic (ELC) (3) Tester, Pulp (EAT) (3) Unit, Electrosurgical, And Accessories, Dental (EKZ) (3) Activator, Ultraviolet, For Polymerization (EBZ) (1)

Premarket Exempt

No Yes

Clear

Sensimatic™ - 00810000520756 Catalog Number : D700SE-230

Device Description : D700SE Sensimatic™ Electrosurge 230volts

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

Sensimatic™ - 00810000520763 Catalog Number : D702

Device Description : Electrode Handpiece and Cable for Sensimatic® 700SE

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

Sensimatic™ - 00810000520770 Catalog Number : D703

Device Description : Indifferent Plate and Cable for SSensimatic® 700SE

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

Thermique™ - 00810000520787 Catalog Number : D531

Device Description : Fine Thermique™ Condenser Tip

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EAT

Prescription Use : Yes

Device Count : 1

Thermique™ - 00810000520794 Catalog Number : D532

Device Description : Medium Thermique™ Condenser Tip

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EAT

Prescription Use : Yes

Device Count : 1

Thermique™ - 00810000520800 Catalog Number : D533

Device Description : Large Thermique™ Condenser Tip

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EAT

Prescription Use : Yes

Device Count : 1

TurboVue™ - 00810000520824 Catalog Number : D570110

Device Description : 110 Volt TurboVue™ 30kHz Ultrasonic Scaler with Lighted Handpiece

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

TurboVue™ - 00810000520831 Catalog Number : D570230

Device Description : 230-Volt TurboVue™ 30kHz Ultrasonic Scaler with Lighted Handpiece

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

TurboVue™ - 00810000520848 Catalog Number : D572

Device Description : Sheath for TurboVue™ Handpiece D570

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Parkell® - 00810000520855 Catalog Number : D559

Device Description : 3-Piece Outlet Adaptor Set for Parkell Curing Light Transformer

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

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