DEN-MAT HOLDINGS, LLC

FDA Device Registration & Listing · Lompoc, CA, US · Registration 2018957

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2018957
FEI Number
2018957
Entity Name
DEN-MAT HOLDINGS, LLC
City/State/Country
Lompoc, CA, US
Establishment Address
1017 W Central Ave, Lompoc, CA 93436, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device
Owner / Operator
DEN-MAT HOLDINGS, LLC (Owner Number: 2018957)
Owner / Operator Contact Address
1017 W. CENTRAL AVENUE, --, Lompoc, CA 93436, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K013674
PMA Number
N/A

All Registered 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 Temptation® Now Fast Set Temporary Crown & Bridge Composite Fluoridex Varnish ViziLite PRO Inspire™ Esthetic Provisional Composite Clinician's Choice® Tubes Universal Tubes & Plugs PERFECtemp II

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ELW Material, Impression Dental Class 2 872.3660 2024-12-23
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2011-01-13
ELW Material, Impression Dental Class 2 872.3660 2024-12-10
DZN Instruments, Dental Hand Dental Class 1 872.4565 2007-12-12
EHL Point, Abrasive Dental Class 1 872.6010 1988-08-02
EMA Cement, Dental Dental Class 2 872.3275 2024-12-10
DZP Instrument, Diamond, Dental Dental Class 1 872.4535 1988-06-10
ELW Material, Impression Dental Class 2 872.3660 2012-03-23
EJQ Wheel, Polishing Agent Dental Class 1 872.6010 2024-12-13
MVL Cord, Retraction Unknown Class U N/A 2024-12-26
ELW Material, Impression Dental Class 2 872.3660 2024-12-03
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2014-12-08
KXR Applicator, Resin Dental Class 1 872.3140 2024-12-13
EBD Coating, Filling Material, Resin Dental Class 2 872.3310 2007-12-12
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2024-12-10
EMA Cement, Dental Dental Class 2 872.3275 2024-12-10
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2024-12-10
MVL Cord, Retraction Unknown Class U N/A 2024-12-10
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2012-04-04
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2014-08-25
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2007-12-12
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2024-12-10
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2024-12-10
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-12-12
EFD Amalgamator, Dental, Ac-Powered Dental Class 1 872.3100 2024-12-13
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2012-04-04
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2014-08-25
EJL Bur, Dental Dental Class 1 872.3240 2008-06-17
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2009-05-12
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2012-04-04
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2023-04-27
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2017-04-19
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2007-12-13
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2024-12-10
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2015-11-23
ELW Material, Impression Dental Class 2 872.3660 2024-12-10
JET Pick, Massaging Dental Class 1 872.6650 2014-04-11
EIH Powder, Porcelain Dental Class 2 872.6660 2007-12-12
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2024-12-10
EIE Dam, Rubber Dental Class 1 872.6300 2007-12-12
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2023-03-03
LBH Varnish, Cavity Dental Class 2 872.3260 2023-03-03
ELW Material, Impression Dental Class 2 872.3660 2012-03-23
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2014-04-11
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2024-12-13
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2024-12-02
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2007-12-12
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2025-02-10
NXV Diagnostic Light, Soft Tissue Detector Dental Class 2 872.6350 2014-04-11
NUX Cleanser, Denture, Prescription Dental Class 1 872.3520 2024-12-13
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 2024-12-13
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2012-06-22
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-12-13
EIE Dam, Rubber Dental Class 1 872.6300 1999-09-20
JEX Plier, Orthodontic Dental Class 1 872.4565 2008-08-11
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2024-12-10
LBH Varnish, Cavity Dental Class 2 872.3260 2021-10-15
NXV Diagnostic Light, Soft Tissue Detector Dental Class 2 872.6350 2016-11-11
EIB Syringe, Irrigating (Dental) Dental Class 1 872.4565 2023-06-29
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2013-09-09
JEW Tip, Rubber, Oral Hygiene Dental Class 1 872.6650 2024-12-10
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2012-04-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DEN-MAT HOLDINGS, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K952614 Dentsply Intl. JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL 1996-08-13
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0028-2020 Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany 2
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.

Similar Registrations

Registration Number Establishment Name Location
3030268763 OWL DENTAL San Leandro, CA, US
8021038 VANNINI DENTAL INDUSTRY SRL GRASSINA(FI) Firenze, IT
3005558160 MAXILL, INC. ST. THOMAS Ontario, CA
9611385 Solventum Germany GmbH SEEFELD Bavaria, DE
2183301 PATTERSON DENTAL SUPPLY, INC. ST. PAUL, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2018957. Last updated year: 2026. Please use registration number 2018957 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.