DEN-MAT HOLDINGS, LLC

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) (5) Toothbrush, Powered (JEQ) (3) Adhesive, Bracket And Tooth Conditioner, Resin (DYH) (1) Coating, Filling Material, Resin (EBD) (1)

Premarket Exempt

No Yes

Clear

DenMat® - D81300701 Catalog Number : 0070

Device Description : BRSH TIP/HANDLE KIT 100pc/2pc

Device Class : 1

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : Yes

Device Count : 2

DenMat® - D81300711 Catalog Number : 0071

Device Description : BRSH TIP KIT 500pc (DISPOSABLE)

Device Class : 1

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : Yes

Device Count : 500

DenMat® - D81300720 Catalog Number : 0072

Device Description : BRSH TIP HANDLE

Device Class : 1

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : Yes

Device Count : 1

Tenure® - D8130301145100 Catalog Number : 030114510

Device Description : TENURE MPB A ADH 6mL RFL KIT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Tenure® - D8130301146100 Catalog Number : 030114610

Device Description : TENURE MPB B ADH 6mL RFL KIT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Ceri-Prime - D8130301255000 Catalog Number : 030125500

Device Description : PORCELAIN REPAIR/PFM KIT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Virtuoso® - D8130303817500 Catalog Number : 030381750

Device Description : VIRTUOSO SEALANT KIT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBD

Prescription Use : Yes

Device Count : 1

Virtuoso® - D8130303818000 Catalog Number : 030381800

Device Description : VIRTUOSO FLOWABLE CUSTOM KIT - 15pc

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Virtuoso® - D8130303819500 Catalog Number : 030381950

Device Description : VIRTUOSO UNIVERSAL KIT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Virtuoso® - D8130303819611 Catalog Number : 030381961

Device Description : VIRT UNIV A3.5 10pc BAGGED

Device Class :

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 10

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