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) (8) Tester, Pulp (EAT) (2)

Premarket Exempt

No Yes

Clear

PerioSonic® - 00810000520343 Catalog Number : D584

Device Description : Model-W PerioSonic® Multi-Fluid Irrigator

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Turbo Piezo™ - 00810000520367 Catalog Number : D690110

Device Description : Turbo Piezo™ Ultrasonic Scaler 110v

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Turbo Piezo™ - 00810000520374 Catalog Number : D690-230

Device Description : Turbo Piezo™ Ultrasonic Scaler 230-volt

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Turbo Piezo™ - 00810000520381 Catalog Number : D691

Device Description : Torque Wrench for Turbo Piezo™ Tips

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Turbo Piezo™ - 00810000520398 Catalog Number : D692

Device Description : Universal Straight Tip for Turbo Piezo™ Ultrasonic Scaler

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Turbo Piezo™ - 00810000520404 Catalog Number : D693

Device Description : Perio Tip for Turbo Piezo™ Ultrasonic Scaler

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Turbo Piezo™ - 00810000520411 Catalog Number : D694

Device Description : Handpiece Only for Turbo Piezo™ Ultrasonic Scaler D690 (100v, 110v & 230v)

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Burnett Power-Tip™ - 00810000520428 Catalog Number : D695

Device Description : Burnett Power-Tip™ for Turbo Piezo™ Ultrasonic Scaler

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Gentle Pulse™ - 00810000520435 Catalog Number : D624MS

Device Description : Gentle Pulse™ Pulp Vitality Tester

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EAT

Prescription Use : Yes

Device Count : 1

Gentle Pulse™ - 00810000520442 Catalog Number : D624MSE

Device Description : Gentle Pulse™ Pulp Vitality Tester

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EAT

Prescription Use : Yes

Device Count : 1

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