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

Powered Laser Surgical Instrument (GEX) (6) Agent, Polishing, Abrasive, Oral Cavity (EJR) (2) Varnish, Cavity (LBH) (2)

Premarket Exempt

No Yes

Clear

FLUORIDEX - D813VN205S0 Catalog Number : VN205S

Device Description : VARNISH STRAWBERRY IN BAG

Device Class : 2

Duns Number: 809857704

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

Pro-DenRx® - D813VNSMPL1 Catalog Number : VNSMPL

Device Description : PRO-DENRx 5% NAF VRNSH SMPL PK

Device Class :

Duns Number: 809857704

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 9

Zen - D813ZENCPBRY61 Catalog Number : ZENCPBRY6

Device Description : ZEN BERRY GEL 6pc

Device Class : 1

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EJR

Prescription Use : No

Device Count : 6

Zen - D813ZENCPMT61 Catalog Number : ZENCPMT6

Device Description : ZEN MINT GEL 6pc

Device Class : 1

Duns Number: 809857704

Premarket Exempt : Yes

Product Code : EJR

Prescription Use : No

Device Count : 6

NV® - D813ZLR10010 Catalog Number : ZLR1001

Device Description : NV MICROLASER

Device Class : 2

Duns Number: 809857704

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NV® - D813ZLR1001L0 Catalog Number : ZLR1001L

Device Description : NV MICROLASER LOANER

Device Class : 2

Duns Number: 809857704

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NV® - D813ZLR1001R0 Catalog Number : ZLR1001R

Device Description : NV MICROLASER REFURBISHED

Device Class : 2

Duns Number: 809857704

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NV® - D813ZLR10060 Catalog Number : ZLR1006

Device Description : NV MICRO BASE CHRGR

Device Class : 2

Duns Number: 809857704

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NV® - D813ZLR10080 Catalog Number : ZLR1008

Device Description : NV MICRO FOOTPEDAL

Device Class : 2

Duns Number: 809857704

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NV® - D813ZLR1012A1 Catalog Number : ZLR1012A

Device Description : NV DISP REG TIPS 5MM 25/PK

Device Class :

Duns Number: 809857704

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 25

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