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

Tester, Pulp (EAT) (6) Scaler, Ultrasonic (ELC) (4)

Premarket Exempt

No Yes

Clear

Gentle Pulse™ - 00810000520459 Catalog Number : D625

Device Description : Metal Probes for Gentle Pulse™ & Digitest™ Pulptesters (1-Short & 1-Long)

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EAT

Prescription Use : Yes

Device Count : 1

Gentle Pulse™ - 00810000520466 Catalog Number : D631ADAPT

Device Description : Ground Clip Lead Wire & Adaptor for Gentle Pulse™ & Digitest™ Pulptesters (Compl Ground Clip Lead Wire & Adaptor for Gentle Pulse™ & Digitest™ Pulptesters (Complies with New FDA Lead Wire Regulation)

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EAT

Prescription Use : Yes

Device Count : 1

Gentle Pulse™ - 00810000520473 Catalog Number : D631GC

Device Description : Ground Clip and Lead Wire for Gentle Pulse™ & Digitest™ Pulptesters

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EAT

Prescription Use : Yes

Device Count : 1

Gentle Pulse™ - 00810000520480 Catalog Number : D636

Device Description : Precision Probe Set for Gentle Pulse™ & Digitest™ Pulptesters (1-each Facial & L Precision Probe Set for Gentle Pulse™ & Digitest™ Pulptesters (1-each Facial & Lingual Probes)

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EAT

Prescription Use : Yes

Device Count : 1

Digitest™ - 00810000520497 Catalog Number : D640

Device Description : Digitest™ II Digital Pulptester

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EAT

Prescription Use : Yes

Device Count : 1

Digitest™ - 00810000520503 Catalog Number : D640E

Device Description : Digitest™ II Digital Pulptester

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EAT

Prescription Use : Yes

Device Count : 1

TurboSENSOR™ - 00810000520527 Catalog Number : D560110

Device Description : TurboSENSOR™ Ultrasonic Scaler 110 Volt

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

TurboSENSOR™ - 00810000520534 Catalog Number : D560-110E

Device Description : TurboSENSOR™ Ultrasonic Scaler 110 Volt

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

TurboSENSOR™ - 00810000520541 Catalog Number : D560-230

Device Description : TurboSENSOR™ Ultrasonic Scaler 230 Volt

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Parkell® - 00810000520572 Catalog Number : D576

Device Description : Parkell® Autoclavable Handpiece Sheath 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

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