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

Material, Impression (ELW) (6) Crown And Bridge, Temporary, Resin (EBG) (4)

Premarket Exempt

No Yes

Clear

SNAP™ - M595S4500 Catalog Number : S450

Device Description : 170gm SNAP™ Resin Shade 69

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SNAP™ - M595S4510 Catalog Number : S451

Device Description : Shade 59 SNAP™ Resin 40gm

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SNAP™ - M595S4520 Catalog Number : S452

Device Description : 170gm SNAP™ Resin Shade 59

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Cinch™ - M595S453S0 Catalog Number : S453S

Device Description : Cinch™ 90 Medium-Body Split-Cartridge System (4-Cartridges & Tips)

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Cinch™ - M595S454S0 Catalog Number : S454S

Device Description : Cinch™ Platinum Medium Body In Split-Cartridge No Clog Auto Mix System (4-Cartri Cinch™ Platinum Medium Body In Split-Cartridge No Clog Auto Mix System (4-Cartridges & Tips)

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Green-Mousse® - M595S455S0 Catalog Number : S455S

Device Description : Green-Mousse® In Split-Cartridge System

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Cinch™ - M595S456S0 Catalog Number : S454S

Device Description : Cinch™ Putty Split-Cartridge System (4-Cartridges & Tips)

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Blu-Mousse® - M595S4570 Catalog Number : S457

Device Description : Super-Fast 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® - M595S457S0 Catalog Number : S457S

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

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Relate™ - M595S458R0 Catalog Number : S458R

Device Description : Relate™ Blue Snap 40gm Resin Refill

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

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