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

Agent, Tooth Bonding, Resin (KLE) (4) Cement, Dental (EMA) (2) Syringe, Restorative And Impression Material (EID) (2) Activator, Ultraviolet, For Polymerization (EBZ) (1) Adhesive, Bracket And Tooth Conditioner, Resin (DYH) (1)

Premarket Exempt

No Yes

Clear

Sapphire® Plus - D8130303952500 Catalog Number : 030395250

Device Description : SAPH WHT CRYSTAL KIT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

Cerinate® - D8130304025501 Catalog Number : 030402550

Device Description : ETCH'N'SEAL RED 8pc SY KIT

Device Class :

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : DYH

Prescription Use : Yes

Device Count : 8

Tenure® - D8130304119000 Catalog Number : 030411900

Device Description : TENURE UNI BOND KIT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Tenure® - D8130304129010 Catalog Number : 030412901

Device Description : TENURE UBOND SOL A 6mL RFL KIT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Tenure® - D8130304129020 Catalog Number : 030412902

Device Description : TENURE UBOND SOL B 6mL RFL KIT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Geristore® - D813030450911B0 Catalog Number : 030450911B

Device Description : GERISTORE A S/S 10g

Device Class : 2

Duns Number: 809857704

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Tenure® - D8130304510100 Catalog Number : 030451010

Device Description : GLOSS 'N' SEAL BAGGED

Device Class : 2

Duns Number: 809857704

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Geristore® - D8130304511100 Catalog Number : 030451110

Device Description : BIO-CAP KIT

Device Class : 2

Duns Number: 809857704

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

DenMat® - D8130305942011 Catalog Number : 030594201

Device Description : TIPS IO WHITE 20pc

Device Class : 1

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EID

Prescription Use : Yes

Device Count : 20

DenMat® - D8130305942051 Catalog Number : 030594205

Device Description : TIP AUTO MIX LG ORF ORG 20pc

Device Class : 1

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EID

Prescription Use : Yes

Device Count : 20

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