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) (4)

Premarket Exempt

No Yes

Clear

Blu-Mousse® - M595S4380 Catalog Number : S438

Device Description : Classic Blu-Mousse® Standard-Cartridge System

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Blu-Mousse® - M595S438S0 Catalog Number : S438S

Device Description : 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

Blu-Mousse® - M595S440S0 Catalog Number : S440S

Device Description : Blu-Mousse® 60 In Split-Cartridge

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

SNAP™ - M595S4410 Catalog Number : S441

Device Description : SNAP™ Liquid Monomer 4oz.

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SNAP™ - M595S4420 Catalog Number : S442

Device Description : 170gm SNAP™ Resin Shade 61

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SNAP™ - M595S4430 Catalog Number : S443

Device Description : 170gm SNAP™ Resin Shade 65

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SNAP™ - M595S4440 Catalog Number : S444

Device Description : 170gm SNAP™ Resin Shade 77

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SNAP™ - M595S4470 Catalog Number : S447

Device Description : 170gm SNAP™ Resin Shade 62

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Blu-Mousse® - M595S448S0 Catalog Number : S448S

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

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

SNAP™ - M595S4490 Catalog Number : S449

Device Description : Shade 69 SNAP™ Resin 40gm

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

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