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

Activator, Ultraviolet, For Polymerization (EBZ) (5) Unit, Electrosurgical, And Accessories, Dental (EKZ) (2) Airbrush (KOJ) (1) Scaler, Ultrasonic (ELC) (1) Tester, Pulp (EAT) (1)

Premarket Exempt

No Yes

Clear

Sensimatic® - 00810000520046 Catalog Number : D601-K

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)(Korea)

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

Parkell® - 00810000520053 Catalog Number : D675

Device Description : Parkell® Aluminum Oxide (50 micron) 5 Lbs.

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : KOJ

Prescription Use : Yes

Device Count : 1

Gentle Pulse™ - 00810000520077 Catalog Number : D636-K

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)(Korea)

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EAT

Prescription Use : Yes

Device Count : 1

Aurora™ - 00810000520091 Catalog Number : D542110

Device Description : 110 Volt Battery Charger for Aurora™ D540

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

Sensimatic™ - 00810000520107 Catalog Number : D703-K

Device Description : Indifferent Plate and Cable for Sensimatic® 700SE (Korea)

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

Aurora™ - 00810000520114 Catalog Number : D544

Device Description : Battery for Aurora™ Curing Light D540

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

TurboSENSOR+™ - 00810000520138 Catalog Number : D565

Device Description : TurboSENSOR +™ 25/30K with removable sheath

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Aurora™ - 00810000520145 Catalog Number : D549

Device Description : Aurora™ S3 Replacement Battery D546

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

Parkell® - 00810000520152 Catalog Number : D553

Device Description : Parkell® Curing Light

Device Class :

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

Parkell® - 00810000520169 Catalog Number : D554

Device Description : Wall Mount Power Transformer for Parkell® D553 Curing Light

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

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