DEN-MAT HOLDINGS, LLC

Address:1017 W Central Ave,Lompoc,CA,93436,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, Tooth Shade, Resin (EBF) (7) Activator, Ultraviolet, For Polymerization (EBZ) (1) Plier, Orthodontic (JEX) (1) Solution, Cement Disolving (KZP) (1)

Premarket Exempt

No Yes

Clear

Core Paste® - D8130306351000 Catalog Number : 030635100

Device Description : C PST WHT DCHMB RFL KIT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Core Paste® - D8130306451000 Catalog Number : 030645100

Device Description : C PST ENM DCHMB D/C RFL KIT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Core Paste® - D8130306521100 Catalog Number : 030652110

Device Description : C PST ENMwFL DCHMB XP SY KIT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Core Paste® - D8130306531100 Catalog Number : 030653110

Device Description : C PST ENM DCHMB XP SY KIT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Core Paste® - D8130306541100 Catalog Number : 030654110

Device Description : C PST WHT DCHMB XP SY KIT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Core Paste® - D8130306551100 Catalog Number : 030655110

Device Description : C PST WHTwFL DCHMB XP SY KIT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Core Paste® - D8130306571100 Catalog Number : 030657110

Device Description : C PST ENMwFL DC XP SY INTRO KT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

LumiGrip® - D8130307521100 Catalog Number : 030752110

Device Description : LUMIGrip SUCTION TIP KIT

Device Class : 1

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : JEX

Prescription Use : Yes

Device Count : 1

Dry-Bond - D8130307550000 Catalog Number : 030755000

Device Description : DRY-BOND 10mL W/INST

Device Class : 2

Duns Number: 809857704

Premarket Exempt : No

Product Code : KZP

Prescription Use : Yes

Device Count : 1

DenMat® - D8130307991050 Catalog Number : 030799105

Device Description : DISPENSING GUN 50mL 1:1

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

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