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) (3)

Premarket Exempt

No Yes

Clear

Sapphire® Plus - D8130305953750 Catalog Number : 030595375

Device Description : CRYSTAL ARM w/HLDR & PIVOT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

Sapphire® Plus - D8130305972750 Catalog Number : 030597275

Device Description : LT SAPH ROLLING STAND W/ARM

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

Sapphire® Plus - D8130305991050 Catalog Number : 030599105

Device Description : DISPENSING GUN 25mL DCHMB SY

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

Core Paste® - D8130306125250 Catalog Number : 030612525

Device Description : CORE PST Q/C W/FLUOR KIT 50g

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Core Paste® - D8130306160000 Catalog Number : 030616000

Device Description : CORE PST ENM SH KIT 50g

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Core Paste® - D8130306160250 Catalog Number : 030616025

Device Description : CORE PST W/FLUOR ENM KIT 50g

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Core Paste® - D8130306163250 Catalog Number : 030616325

Device Description : CORE PST ENM SH Q/C KIT 50g

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Core Paste® - D8130306173250 Catalog Number : 030617325

Device Description : CORE PST BLU S/C KIT 50g

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Core Paste® - D8130306221000 Catalog Number : 030622100

Device Description : CORE PST W/FL KIT 50g

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Core Paste® - D8130306251000 Catalog Number : 030625100

Device Description : C PST WHT w/FL DCHMB RFL KIT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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