Manufacturer registered with FDA
Den-Mat Holdings, LLC
Lompoc, CA, United States. Lists 37 dental device types with FDA across 1 registered establishment, and holds 8 510(k) clearances as applicant.
- Device types listed
- 37
- Brands and models
- 156
- 510(k) clearances
- 82008–2026
- Markets registered in
- 11125 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 11 markets
Where regulators' registries name Den-Mat Holdings, LLC as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Den-Mat Holdings, LLC | 8 clearances | 2008–2026 | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | DEN-MAT HOLDINGS, LLCDenMat Holdings, LLC | 36 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DENMAT HOLDINGS, LLC.DEN-MAT HOLDINGS, LLC · DENMAT HOLDINGS, LLC | 32 | 2012–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | DEN-MAT HOLDINGS, LLCDenMat Holdings, LLC · Den-Mat Holdings LLC · +1 | 21 | 2001–2017 | Pure Global AI |
| Australia | TGA | Manufacturer | Den-Mat Holdings LLC | 13 | 2008–2020 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Den-Mat Holdings, LLC | 12 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | DEN-MAT HOLDINGS, LLC | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | DEN-MAT Holdings, LLCDen-Mat holdings , LLC | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DENMAT HOLDINGS, LLC | 1 | 2020–2020 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Den-Mat Holdings, LLC | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DENMAT HOLDINGS, LLC | 1 | 2018–2018 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Den-Mat Holdings, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Cerinate Shade Modification SystemCore PasteDenMat Bulk FillDenMat TenureEvanesce Bulk FillEvanesce Flow Flowable RestorativeEvanesce Injectable RestorativeEvanesce Nano-Enhanced Universal RestorativeEvanesce Silk Nano-Enhanced Universal RestorativeMax Etch 10 moreMax Etch 35% Phosphoric AcidNuance FLOWNuance UniversalPorcelain Repair KitResin Blend LV Composite Wetting Resin & LubricantTenure MPBTetrapaqueVirtuoso FlowableVirtuoso UniversalZircules Zirconia Nano-Filled Core Material | 2007 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | Acu-FlowAffinity Crystal Clear Matrix Impression MaterialAffinity Multi-Prep Extended Working Time Impression MaterialAffinity Quick Bite Registration MaterialAffinity Quick Bite Registration MaterialAffinity Tray AdhesiveChocolate BiteClear BiteCounterFit II Multi-Purpose Replication SiliconeMega Bite 7 morePrecision VPSSplash MaxSplash!Template PuttyTemplate® Ultra Quick Matrix MaterialVanilla Bite3rd Generation Affinity Hydroactive Impression Material | 2012 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | BondLinkG-BLOCKG5G5 All-Purpose DesensitizerGloss 'N' SealLumiBrite Desensitizing EnhancerMPa Universal Dual-Cure CatalystMPa Universal Light-Cure Universal AdhesiveTenure Quik with FluorideTenure S 3 moreTenure Uni-BondTenure4GZirconia Prime | 2007 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | Inspire Esthetic Provisional CompositePERFECtemp IITemptation® Now Fast Set Temporary Crown & Bridge Composite | 2012 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | FLASHlite 2FLASHlite Magna 4Sapphire Plus Plasma Arc Curing Light | 2009 |
| Dental CementEMA · Class 2 | Dental cements | Maker | Bio-CapBlock-Out Try-InCling2® Resin Optimized Temporary CementDuo:PCH CementGeristoreGlisten Provisional Resin GlazeGoldLink 2HolistoreInfinityInfinity SE 3 moreUltra-Bond ClearUltra-Bond PlusUltra-Bond Try-In | 2007 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | CeriSanderCeriSawClinician's Choice® Composite NinjaCompo-jectContoured Wood WedgesConvexi-T Convex Tofflemire Matrix BandsDualForce Sectional Matrix System - Rings, Bands, Wedges, Metal InstrumentsEsthetic Contouring InstrumentsMatrix StripsOcclusal Reduction Rings 3 morePowerMix Cartridge ConnectorREJ Composite InstrumentsSchure 349 | 1988 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Edge DamPaint-On Dental DamTrue Dental Dam | 1999 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Contours Coarse Anatomy TrimmersD Fine Diamond Polishers For Hybrid CompositesD Fine Double Diamond Polishing System for Hybrid Composites and PorcelainPorcelain Laminate Polishing Paste | 1988 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | Fluoridex VarnishG-BLOCKG5 | 2021 |
| Soft Tissue Detector Diagnostic LightNXV · Class 2 | — | Maker | Vizilite EyewearViziLite PRO | 2014 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Maker | Cerinate PrimeEtch 'N' SealEtchantPorcelain ConditionerPorcelock | 2007 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | CleanCut Extended Use DiamondExtra-Fine Smoothing DiamondFootball DiamondInterproximal Mosquito DiamondPorcelain Ledge Diamond | 1988 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | Vizilite TBlue | 2014 |
| Resin Filling Material CoatingEBD · Class 2 | — | Maker | Virtuoso SealantVisar Seal | 2007 |
| Ac-Powered Dental AmalgamatorEFD · Class 1 | — | Lister | PowerMix Automatic Impression Material Dispenser | 2024 |
| Articulation PaperEFH · Class 1 | — | Lister | Articulating Film | 2023 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Lister | A.S.A.P.® All Surface Access PolishersA.S.A.P.® DailiesA.S.A.P.® Diamond Polishing BrushesA.S.A.P.® Indrect+ All Surface Access Polishers ExtraoralA.S.A.P.® Indrect+ All Surface Access Polishers IntraoralContours Finishing & Polishing Discs | 1988 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Lister | Groovy Diamond® Polishing Brushes | 1988 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Border-Lock® Impression TraysClear Impression TraysHeatWave Customizable Impression TraysPerfectrayPosterior TempTrayQuad-Tray®Quad-Tray® Ultimate PosteriorSymmetry Facial Plane RelatorThe Gripper | 2012 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Maker | — | 2023 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | Bulkcure TipsDual Port Impression GunEndoFlex TipsEvanesce Injectable tipInspire/Temptation Dispensing GunIntraoral TipsMixing TipsPowerMix Dynamic Mixing TipsZircules Mini 1:1 Dispensing Gun | 2024 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | DenMat Multilayered Zirconia Disc | 2026 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Lister | Clinician's Choice® Micropoint Scissors | 2024 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Lister | AdvantEdgeDualForce Matrix Forceps | 2024 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Polishing CupPolishing Point | 2008 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Lister | Final Shine Cotton Polishing Wheels | 2024 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | Pro-Select Platinum | 2014 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Lister | Core Post | 1988 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Rotadent ClassicRotadent ContourRotadent PlusRotadent ProCare | 2014 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | RotaPoint | 2014 |
| Oral Hygiene Rubber TipJEW · Class 1 | Floss & interdental cleaners | Lister | Clinician's Choice® TubesUniversal Tubes & Plugs | 2024 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | LUMIGrip | 2008 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | Perio Tray | 2025 |
| Resin ApplicatorKXR · Class 1 | — | Lister | Multi-Brush® Disposable Dental Applicator | 2024 |
| Cement Dissolving SolutionKZP · Class 2 | — | Maker | Dry-BondSolvenex | 2007 |
| Prescription Denture CleanserNUX · Class 1 | — | Lister | Detail Pre-Impression Cleansing Gel | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Den-Mat Holdings, LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 24 Sep 2026 | K262252 | MPa Max adhesive | KLE Resin Tooth Bonding Agent |
| 15 Oct 2024 | K242097 | DenMat Bulk Fill Composite | EBF Resin Tooth Shade Material |
| 20 Dec 2019 | K192470 | DenMat Orthodontic Aligners | NXC Sequential Aligner |
| 24 Mar 2017 | K162967 | nuance UNIVERSAL | EBF Resin Tooth Shade Material |
| 1 May 2015 | K143679 | Nuance FLOW | EBF Resin Tooth Shade Material |
| 20 Aug 2014 | K140537 | TENURE4G | KLE Resin Tooth Bonding Agent |
| 21 Nov 2008 | K081287 | SAPPHIRE PLASMA ARC DENTAL CURING LIGHT | EBZ Ultraviolet Activator for Polymerization |
| 3 Apr 2008 | K073483 | SAPPHIRE O/E ORAL EXAMINATION SYSTEM | NXV Soft Tissue Detector Diagnostic Light |
Also lists devices cleared under other names
Den-Mat Holdings, LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: S & C Polymer GmbH (8), Den-Mat Corp. (8), Philips Medical Systems International BV (5), Denmat Holding, LLC (2), Kettenbach GmbH & Co. KG (2), Ultradent Products, Inc. (2), Apex Dental Materials, Inc. (2), Voco GmbH (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 25 Aug 2025 | K251593 | DenMat Multilayered Zirconia Disc | Denmat Holding, LLC | EIH Porcelain Powder |
| 27 Apr 2023 | K223892 | DentMix VPS Impression Material | Innovative Product Brands, Inc. | ELW Impression Material |
| 9 Aug 2022 | K222357 | DenMat Glutaraldehyde Desensitizer | Denmat Holding, LLC | KLE Resin Tooth Bonding Agent |
| 18 Sep 2013 | K124025 | ALPHA-PRO WHITE VARNISH | Dental Technologies, Inc. | LBH Cavity Varnish |
| 27 Dec 2012 | K122039 | KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B | Kettenbach GmbH & Co. KG | EBG Resin Temporary Crown and Bridge |
| 21 Sep 2011 | K111876 | Z BOND, PRELUDE ONE | Danville Materials, LLC | KLE Resin Tooth Bonding Agent |
| 16 Jul 2010 | K100752 | PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) | Ultradent Products, Inc. | KLE Resin Tooth Bonding Agent |
| 1 Oct 2009 | K092539 | SEAMFREE | Apex Dental Materials, Inc. | EBF Resin Tooth Shade Material |
| 23 Jul 2009 | K091894 | TEMPORARY C&B COMPOSITE | Voco GmbH | EBG Resin Temporary Crown and Bridge |
| 23 Jan 2009 | K082668 | BIO-SCREEN | Addent, Inc. | NXV Soft Tissue Detector Diagnostic Light |
| 15 Jan 2009 | K082115 | PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT | S & C Polymer GmbH | EMA Dental Cement |
| 4 Aug 2008 | K081017 | TEMPLATE AND COUNTER-FIT | Clinician'S Choice Dental Products, Inc. | ELW Impression Material |
| 1 May 2008 | K081120 | FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS | Kettenbach GmbH & Co. KG | ELW Impression Material |
| 4 Apr 2008 | K080043 | VIZILITE EYEWEAR | Zila, Inc. | NXV Soft Tissue Detector Diagnostic Light |
| 20 Dec 2007 | K073518 | FLASHLITE REBEL* | Philips Medical Systems International BV | EBZ Ultraviolet Activator for Polymerization |
| 12 Dec 2007 | K073005 | ELITE GLASS | Dentsply Sirona, Inc. | ELW Impression Material |
| 15 Nov 2005 | K053014 | POLY SILOXANE IMPRESSION MATERIAL | Clinician'S Choice Dental Products, Inc. | ELW Impression Material |
| 8 Nov 2005 | K053018 | POLY SILOXANE IMPRESSION MATERIAL | Millennium Dental International, Inc. | ELW Impression Material |
| 5 Aug 2005 | K052090 | SPLASH! IMPRESSION MATERIAL DEVICE | Philips Medical Systems International BV | ELW Impression Material |
| 22 Nov 2004 | K042614 | S&C-SELF ETCH PR-BOND | S & C Polymer GmbH | KLE Resin Tooth Bonding Agent |
| 22 Nov 2004 | K033033 | VIZILITE-BLUE ORAL EXAM KIT | Trylon Corp. | EAZ Dental Operating Light |
| 7 Apr 2004 | K040769 | STRUCTUR 2 SC | Voco GmbH | EBG Resin Temporary Crown and Bridge |
| 25 Mar 2004 | K040053 | PRECISION VPS IMPRESSION MATERIAL | Philips Medical Systems International BV | ELW Impression Material |
| 9 May 2003 | K030776 | MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL | Philips Medical Systems International BV | ELW Impression Material |
| 17 Jan 2003 | K023748 | FLASH-LITE II LED DENTAL CURING LIGHT | Philips Medical Systems International BV | EBZ Ultraviolet Activator for Polymerization |
| 24 Jan 2002 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | Dmg USA, Inc. | EBG Resin Temporary Crown and Bridge |
| 1 Nov 2001 | K012767 | S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL | S & C Polymer GmbH | ELW Impression Material |
| 14 Sep 2001 | K010849 | VERTEX ETCHANT | Apex Dental Materials, Inc. | EBF Resin Tooth Shade Material |
| 2 Nov 1999 | K992001 | TRAY-LINK | Silicon-Und Composite Spezialitaten GmbH | ELW Impression Material |
| 9 Mar 1999 | K990108 | LC FLOWFILL | S & C Polymer GmbH | EBF Resin Tooth Shade Material |
| 9 Feb 1999 | K984097 | DC-CORE | S & C Polymer GmbH | EBF Resin Tooth Shade Material |
| 20 Jan 1999 | K984484 | LC MICROHYBRID | S & C Polymer GmbH | EBF Resin Tooth Shade Material |
| 5 Jun 1998 | K973201 | PROVI CEMENT | S & C Polymer GmbH | EMA Dental Cement |
| 22 Apr 1997 | K964596 | PROSELECT 3 PERIDONTAL THERAPY SYSTEM | Professional Dental Mfg., Inc. | ELC Ultrasonic Scaler |
| 3 Oct 1995 | K953504 | MICROPRIME | Danville Engineering, Inc. | KLE Resin Tooth Bonding Agent |
| 31 Mar 1995 | K951075 | S & C VINYL POLYSILOXANE IMPRESSION MATERIAL | S & C Polymer GmbH | ELW Impression Material |
| 9 Sep 1993 | K931867 | ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE | Ultradent Products, Inc. | EBF Resin Tooth Shade Material |
| 15 Jul 1988 | K881918 | LIGHT-CURED ZIONOMER CEMENT | Den-Mat Corp. | EMA Dental Cement |
| 24 Aug 1987 | K872510 | DEN-MAT TENURE | Den-Mat Corp. | EBF Resin Tooth Shade Material |
| 18 Dec 1985 | K852630 | DEN-MAT PAINT-ON RUBBER DAM | Den-Mat Corp. | EIE Rubber Dam |
| 30 Mar 1984 | K841111 | REMBRANDT SHADE MODIFICATION KIT | Den-Mat Corp. | EBF Resin Tooth Shade Material |
| 17 Jun 1980 | K801225 | DEN-MAT POLISHING PASTE | Den-Mat Corp. | EJR Oral Cavity Abrasive Polishing Agent |
| 28 May 1980 | K801216 | DEN-MAT DENTIN BONDING AGENT | Den-Mat Corp. | KLE Resin Tooth Bonding Agent |
| 12 Jan 1978 | K771974 | SOLVENEX I-0 | Den-Mat Corp. | KZP Cement Dissolving Solution |
| 3 Jan 1978 | K772316 | MATRIX STRIP, DEAD-SOFT | Den-Mat Corp. | DZN Dental Hand Instruments |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DEN-MAT HOLDINGS, LLCFDA reg. 2018957 | Lompoc, CA, United States | Complaint file establishment, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2018957). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.