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

Crown And Bridge, Temporary, Resin (EBG) (6) Material, Impression (ELW) (3) Cement, Dental (EMA) (1)

Premarket Exempt

No Yes

Clear

NA - M595S4130 Catalog Number : S413

Device Description : MTL-V Primer 3ml.

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

SNAP™ - M595S4240 Catalog Number : S424

Device Description : SNAP™ Intro Kit (4-Powders & 1-Liquid)

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SNAP™ - M595S4250 Catalog Number : S425

Device Description : Shade 61 SNAP™ RESIN 40gm

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SNAP™ - M595S4260 Catalog Number : S426

Device Description : Shade 65 SNAP™ Resin 40gm

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SNAP™ - M595S4270 Catalog Number : S427

Device Description : Shade 77 SNAP™ Resin 40gm

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SNAP™ - M595S4290 Catalog Number : S429

Device Description : CLEAR SNAP™ Resin 40gm

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SNAP™ - M595S4340 Catalog Number : S434

Device Description : 170gm CLEAR SNAP™ Resin

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Cinch™ - M595S4350 Catalog Number : S435

Device Description : Cinch™ Platinum Tubes (Contains: 2-Tubes Base & 2-Tubes Catalyst)

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Blu-Mousse® - M595S4360 Catalog Number : S436

Device Description : Tubes Classic Blu-Mousse®

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Blu-Mousse® - M595S437S0 Catalog Number : S437S

Device Description : Peppermint Classic Blu-Mousse® In Split-Cartridge System

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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