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) (7) Cement, Dental (EMA) (2) Material, Impression (ELW) (1)

Premarket Exempt

No Yes

Clear

NA - M595S397AP150 Catalog Number : S397AP15

Device Description : AP-1 1/2 Electrosurge Electrode

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

NA - M595S397C030 Catalog Number : S397C03

Device Description : C-3 Electrosurge Electrode

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

NA - M595S397P040 Catalog Number : S397P04

Device Description : P4 Proximal Hemostasis Electrosurge Electrode

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

NA - M595S397T020 Catalog Number : S397T02

Device Description : T-2 Electrosurge Electrode

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

NA - M595S397T050 Catalog Number : S397T05

Device Description : T-5 Electrosurge Electrode

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

NA - M595S397T080 Catalog Number : S397T08

Device Description : T-8 Electrosurge Electrode

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

NA - M595S397T160 Catalog Number : S397T16

Device Description : T-16 Electrosurge Electrode

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EKZ

Prescription Use : Yes

Device Count : 1

METABOND® - M595S3980 Catalog Number : S398

Device Description : ‘B’ Quick Base 10ml. for C&B METABOND®

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

METABOND® - M595S3990 Catalog Number : S399

Device Description : L-Powder Clear 3 grams for C&B METABOND®

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

TriPhasix™ - M595S4000 Catalog Number : S400

Device Description : 1lb. TriPhasix™ Chromatic Alginate

Device Class :

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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