FDA.reportPublic FDA data

DEN-MAT HOLDINGS, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20189572018957DEN-MAT HOLDINGS, LLC1Y2026-01-011017 W Central Ave Lompoc CA US 93436

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00359883005214Max Etch 35% Phosphoric Acid Etch 30mL - Dental Etchant+1(800)433-6628info@denmat.com
00359883005221Max Etch 35% Phosphoric Acid Etch 5mL - Dental Etchant+1(800)433-6628info@denmat.com
00359883007218EVANESCE - INJECTABLE SYRING TIPS1-800-433-6628INFO@DENMAT.COM
D8130301255000Ceri-Prime - PORCELAIN REPAIR/PFM KIT1-800-433-6628info@denmat.com
D8130303761050GBLOCK - GBLOCK DESENSITIZER 5ml1-800-433-6628info@denmat.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
339851427864555K992001TRAY-LINKELW1999-11-02
339851464572916K990108LC FLOWFILLEBF1999-03-09
339851432788257K984484LC MICROHYBRIDEBF1999-01-20
339851384576951K984097DC-COREEBF1999-02-09
339851829120225K981596ULTRAPAK EMVL1998-07-31
339852055748024K973201PROVI CEMENTEMA1998-06-05
339851273230083K964596PROSELECT 3 PERIDONTAL THERAPY SYSTEMELC1997-04-22
339851653868974K953504MICROPRIMEKLE1995-10-03
339851181640540K951075S & C VINYL POLYSILOXANE IMPRESSION MATERIALELW1995-03-31
339851535103085K931867ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINEEBF1993-09-09
339851159777296K895731DEN-MAT CERINATE PORCELAINEIH1990-08-03
339851579486173K895269DEN-MAT LAMI-QUICKELL1990-02-22
339851824466169K881918LIGHT-CURED ZIONOMER CEMENTEMA1988-07-15
339851898544460K872510DEN-MAT TENUREEBF1987-08-24
339851782161605K852630DEN-MAT PAINT-ON RUBBER DAMEIE1985-12-18
339851754425470K841111REMBRANDT SHADE MODIFICATION KITEBF1984-03-30
339851129869966K801225DEN-MAT POLISHING PASTEEJR1980-06-17
339851440818788K801216DEN-MAT DENTIN BONDING AGENTKLE1980-05-28
339851122384559K772316MATRIX STRIP, DEAD-SOFTDZN1978-01-03
339851262945240K771974SOLVENEX I-0KZP1978-01-12
339851478791080K251593DenMat Multilayered Zirconia DiscEIH2025-08-25
339851205371472K242097DenMat Bulk Fill CompositeEBF2024-10-15
339851274420269K223892DentMix VPS Impression MaterialELW2023-04-27
339851908318677K222357DenMat Glutaraldehyde DesensitizerKLE2022-08-09
339851209726554K162967nuance UNIVERSALEBF2017-03-24
339851496997411K143679Nuance FLOWEBF2015-05-01
339851563225743K141838SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL)GEX2014-07-25
339851977066862K140537TENURE4GKLE2014-08-20
339851912486653K124025ALPHA-PRO WHITE VARNISHLBH2013-09-18
339851276200540K122039KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS BEBG2012-12-27
339851480553283K111876Z BOND, PRELUDE ONEKLE2011-09-21
339851034966046K110079SPPHINE PLUS STM 3W DIODE LASERGEX2011-02-10
339851572525030K103667SAPPHIRE ST PORTABLE DIODE LASERGEX2010-12-29
339851304695311K102639SL3GEX2010-12-01
339851862758817K101612ZEN CORDLESS PROPHY SYSTEMEKX2010-06-30
339851989493639K101215NUANCEEBF2010-05-12
339851407917736K100752PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)KLE2010-07-16
339851099324886K092539SEAMFREEEBF2009-10-01
339851292545992K092417INSIGHT ULTRASONIC INSERTSELC2009-12-11
339851695543672K091894TEMPORARY C&B COMPOSITEEBG2009-07-23
339851381165894K091796SOFTLASE PRO, ORTHOLASE AND HYGIENELASEGEX2009-07-31
339851319944179K082668BIO-SCREENNXV2009-01-23
339851954953627K082115PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECTEMA2009-01-15
339851545544562K081287SAPPHIRE PLASMA ARC DENTAL CURING LIGHTEBZ2008-11-21
339851819646374K081214STYLA MICROLASER AND STYLAORTHOGEX2008-05-14
339851917385513K081120FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALSELW2008-05-01
339851431169448K081017TEMPLATE AND COUNTER-FITELW2008-08-04
339852057624358K080043VIZILITE EYEWEARNXV2008-04-04
339851217520568K073518FLASHLITE REBEL*EBZ2007-12-20
339852044602970K073483SAPPHIRE O/E ORAL EXAMINATION SYSTEMNXV2008-04-03
339851066488636K073005ELITE GLASSELW2007-12-12
339851330934471K053018POLY SILOXANE IMPRESSION MATERIALELW2005-11-08
339851030883862K053014POLY SILOXANE IMPRESSION MATERIALELW2005-11-15
339851738340486K052090SPLASH! IMPRESSION MATERIAL DEVICEELW2005-08-05
339851952876759K042614S&C-SELF ETCH PR-BONDKLE2004-11-22
339851818990251K040769STRUCTUR 2 SCEBG2004-04-07
339851485586904K040053PRECISION VPS IMPRESSION MATERIALELW2004-03-25
339851846944002K033033VIZILITE-BLUE ORAL EXAM KITEAZ2004-11-22
339851325656074K030776MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIALELW2003-05-09
339851172687450K023748FLASH-LITE II LED DENTAL CURING LIGHTEBZ2003-01-17
339851040762415K022032ACETALEHP2002-08-29
339851132413408K013969MINIBLASTERKOJ2002-01-10
339851212564609K013674LUXATEMP/LUXATEMP SOLAR/INSTATEMPEBG2002-01-24
339851201172840K012767S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIALELW2001-11-01
339851114850491
339851143157846
339851187687801
339851449554340
339851551033673
339851625114901
339851688129256
339851850941634
339851860589457
339851892009691
339851991747394
339851994087524
339852017765084
339851027326403
339851048383136
339851050072447
339851071148575
339851190606961
339851321800315
339851339360315
339851402342252
339851419624816
339851420042715
339851495575174
339851500433002
339851500519791
339851506555229
339851539616664
339851602366900
339851652334963
339851680738325
339851687947109
339851759917623
339851763172351
339851828939268
339851834223041
339851864435085
339851881256760
339851963770745
339851971715855
339852021045453
339852021952902
339852056576973

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ELW122023-04-27
EBF112024-10-15
KLE72022-08-09
GEX62014-07-25
EBG42012-12-27
NXV32009-01-23
EMA32009-01-15
EBZ32008-11-21
EIH22025-08-25
ELC22009-12-11
LBH12013-09-18
EKX12010-06-30
EAZ12004-11-22
EHP12002-08-29
KOJ12002-01-10
MVL11998-07-31
ELL11990-02-22
EIE11985-12-18
EJR11980-06-17
KZP11978-01-12
DZN11978-01-03

NDC#

Fluoridex

DEN-MAT HOLDINGS, LLC

Stannous Fluoride Rinse

FLUORIDEX

DEN-MAT HOLDINGS, LLC.

Sodium Fluoride

FLUORIDEX

DEN-MAT HOLDINGS, LLC.

Sodium Fluoride

kids kare

DEN-MAT HOLDINGS, LLC.

Stannous Fluoride

Kids Kare

DEN-MAT HOLDINGS, LLC.

Sodium Fluoride

PMN#

GUDID#

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