BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DEN-MAT HOLDINGS, LLC

    Reg #: 2018957 · FEI: 2018957 · Expires 2026
    View on FDA
    Products
    42
    Proprietary Names
    166
    Establishment Types
    4
    Classifications
    42

    Registration Details

    Registration Name
    DEN-MAT HOLDINGS, LLC
    Registration Number
    2018957
    FEI Number
    2018957
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1017 W Central Ave
    City
    Lompoc
    State
    CA
    ZIP
    93436
    Country
    US

    Regulatory Submissions

    510(k) Number
    K053018

    Owner / Operator

    Firm Name
    DEN-MAT HOLDINGS, LLC
    Operator Number
    2018957
    Address
    1017 W. CENTRAL AVENUE, --
    City
    Lompoc
    State
    CA
    Postal Code
    93436
    Country
    US

    Products

    Device Name Product Code
    Material, Impression ELW
    Powered Laser Surgical Instrument GEX
    Instruments, Dental Hand DZN
    Point, Abrasive EHL
    Cement, Dental EMA
    Instrument, Diamond, Dental DZP
    Wheel, Polishing Agent EJQ
    Cord, Retraction MVL
    Material, Tooth Shade, Resin EBF
    Applicator, Resin KXR
    Coating, Filling Material, Resin EBD
    Crown And Bridge, Temporary, Resin EBG
    Agent, Tooth Bonding, Resin KLE
    Activator, Ultraviolet, For Polymerization EBZ
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Amalgamator, Dental, Ac-Powered EFD
    Tray, Impression, Preformed EHY
    Bur, Dental EJL
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Pick, Massaging JET
    Powder, Porcelain EIH
    Dam, Rubber EIE
    Varnish, Cavity LBH
    Handle, Instrument, Dental EJB
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Diagnostic Light, Soft Tissue Detector NXV
    Cleanser, Denture, Prescription NUX
    Syringe, Restorative And Impression Material EID
    Plier, Orthodontic JEX
    Syringe, Irrigating (Dental) EIB
    Tip, Rubber, Oral Hygiene JEW
    Loupe, Binocular, Low Power HJH
    Paper, Articulation EFH
    Light, Examination, Medical, Battery Powered KYT
    Post, Root Canal ELR
    Scissors, Collar And Crown EIR
    Tray, Fluoride, Disposable KMT
    Solution, Cement Dissolving KZP
    Scaler, Ultrasonic ELC
    Disk, Abrasive EHJ
    Toothbrush, Powered JEQ
    Light, Operating, Dental EAZ

    Proprietary Names

    Acu-Flow™ SOL Affinity™ Multi-Prep™ Extended Working Time Impression Material Affinity Quick Bite Registration Material Matrix Strips Groovy Diamond® Polishing Brushes Cling2® Resin Optimized Temporary Cement CleanCut™ Extended Use Diamond Porcelain Ledge Diamond Interproximal Mosquito Diamond Football Diamond Extra-Fine Smoothing Diamond Precision VPS Final Shine Cotton Polishing Wheels Tissue Goo™ Template® Ultra Quick Matrix Material Evanesce™ Flow Flowable Restorative Evanesce™ Injectable Restorative Multi-Brush® Disposable Dental Applicator Virtuoso Sealant Visar Seal Temptation® Now Fast Set Temporary Crown & Bridge Composite Glisten™ Provisional Resin Glaze G5™ All-Purpose Desensitizer Re-Cord ™ Knitted Retraction Cord FLASHlite Magna 4 Tenure4G Porcelain Laminate Polishing Paste MPa Universal™ Dual-Cure Catalyst MPa Universal™ Light-Cure Universal Adhesive Resin Blend LV Composite Wetting Resin & Lubricant Porcelain Repair Kit Core Paste Virtuoso Flowable Virtuoso Universal PowerMix™ Automatic Impression Material Dispenser The Gripper Perfectray Quad-Tray® Ultimate™ Posterior Clear Impression Trays Symmetry Facial Plane Relator HeatWave™ Customizable Impression Trays Quad-Tray® Border-Lock® Impression Trays Posterior TempTray SOL Portable Diode Laser Unit (with wireless foot control) BlueWave Laser Polishing Point Polishing Cup Sapphire Plus Plasma Arc Curing Light FLASHlite 2 Zirconia Prime Nuance Universal Tenure S BondLink LumiBrite Desensitizing Enhancer Tenure Quik with Fluoride Tenure Uni-Bond Gloss 'N' Seal Max Etch 35% Phosphoric Acid PeriOptix Eyeshield Diode Laser Eyewear Affinity Tray Adhesive RotaPoint Cerinate Porcelain Zircules™ Zirconia Nano-Filled Core Material Paint-On Dental Dam G-BLOCK G5 Splash Max Splash! NV PRO3 Microlaser DualForce™ Matrix Forceps AdvantEdge DenMat Bulk Fill Evanesce Bulk Fill Porcelock Porcelain Conditioner Etch 'N' Seal Cerinate Prime Etchant Vizilite Eyewear Detail™ Pre-Impression Cleansing Gel Inspire/Temptation Dispensing Gun Zircules™ Mini 1:1 Dispensing Gun PowerMix™ Dynamic Mixing Tips EndoFlex Tips Evanesce Injectable tip Dual Port Impression Gun Bulkcure Tips Intraoral Tips Mixing Tips Evanesce™ Nano-Enhanced Universal Restorative Evanesce™ Silk Nano-Enhanced Universal Restorative Cerinate Shade Modification System Tetrapaque True Dental Dam Edge Dam LUMIGrip Fluoridex Varnish ViziLite PRO Inspire™ Esthetic Provisional Composite Clinician's Choice® Tubes Universal Tubes & Plugs PERFECtemp II PeriOptix Loupes including TTLs Articulating Film Contours™ Coarse Anatomy Trimmers D Fine Double Diamond™ Polishing System for Hybrid Composites and Porcelain D Fine™ Diamond Polishers For Hybrid Composites CounterFit™ II Multi-Purpose Replication Silicone Microline Mini Headlights Firefly Cordless Headlights LumiPro LED Headlight System Core Post Tenure MPB DenMat Tenure Template Putty 3rd Generation Affinity™ Hydroactive Impression Material Duo:PCH Cement Holistore Geristore Infinity Block-Out Try-In Infinity SE Ultra-Bond Clear Ultra-Bond Plus GoldLink 2 Ultra-Bond Try-In Bio-Cap Vanilla Bite Chocolate Bite Clear Bite Mega Bite Nuance FLOW Affinity™ Quick Bite Registration Material Affinity™ Crystal Clear Matrix Impression Material Compo-ject Clinician's Choice® Composite Ninja CeriSander CeriSaw Schure 349 Esthetic Contouring Instruments PowerMix™ Cartridge Connector Occlusal Reduction Rings DualForce™ Sectional Matrix System - Rings, Bands, Wedges, Metal Instruments Contoured Wood Wedges Convexi-T™ Convex Tofflemire Matrix Bands REJ Composite Instruments Clinician's Choice® Micropoint Scissors Perio Tray DenMat Multilayered Zirconia Disc Dry-Bond Solvenex Pro-Select Platinum A.S.A.P.® All Surface Access Polishers A.S.A.P.® Dailies Contours™ Finishing & Polishing Discs A.S.A.P.® Indrect+ All Surface Access Polishers Intraoral A.S.A.P.® Diamond Polishing Brushes A.S.A.P.® Indrect+ All Surface Access Polishers Extraoral Rotadent Classic Rotadent Contour Rotadent Plus Rotadent ProCare Vizilite TBlue

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility