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

Resin, Denture, Relining, Repairing, Rebasing (EBI) (7) Material, Impression (ELW) (2) Crown And Bridge, Temporary, Resin (EBG) (1)

Premarket Exempt

No Yes

Clear

SNAP™ - M595S4820 Catalog Number : S482

Device Description : 170gm Characterized Pink SNAP™ Resin

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

MucoHard™ - M595S4850 Catalog Number : S485

Device Description : MucoHard™ Bonding Liner with 6-Brushes & 6-Pipettes

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

MucoHard™ - M595S4860 Catalog Number : S486

Device Description : MucoHard™ Resin Refill Cartridge with Tips

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

MucoHard™ - M595S4870 Catalog Number : S487

Device Description : MucoHard™ Hard Denture Reline Kit

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

MucoSoft® - M595S491S0 Catalog Number : S491S

Device Description : MucoSoft® Soft Denture Reline Kit

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

MucoSoft® - M595S492S0 Catalog Number : S492S

Device Description : Refill MucoSoft® Reline Silicone: (1 Cartridge & 10 Tips)

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

MucoSoft® - M595S4930 Catalog Number : S493

Device Description : MucoSoft® Glaze (Bottles A & B)

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

MucoSoft® - M595S4940 Catalog Number : S494

Device Description : MucoSoft® Bonding Liner (Adhesive)

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

SHARP™ - M595S5100 Catalog Number : S510

Device Description : SHARP™ Wash Premium Hydrophilic VPS Impression Material

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

SHARP™ - M595S5110 Catalog Number : S511

Device Description : SHARP™ Medium Body Premium Hydrophilic VPS Impression Material

Device Class : 2

Duns Number: 009900424

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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