Data / Medical devices / United States / Den-Mat Holdings, LLC
Den-Mat Holdings, LLC: FDA-registered device maker in Lompoc, CA, United States, 53 510(k) clearances
Den-Mat Holdings, LLC is registered with the FDA (registration 2018957) in Lompoc, CA, United States. It lists 42 device types. The FDA files 53 510(k) clearances under its listings, the newest dated August 25, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2018957
- Address
- 1017 W Central Ave, Lompoc, CA, United States, 93436
- Owner or operator
- DEN-MAT HOLDINGS, LLC (2018957)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- June 10, 1988
- Registered through
- 2026
- Brand names listed
- 3rd Generation Affinity Hydroactive Impression Material, A.S.A.P.® All Surface Access Polishers, A.S.A.P.® Dailies, A.S.A.P.® Diamond Polishing Brushes, A.S.A.P.® Indrect+ All Surface Access Polishers Extraoral, A.S.A.P.® Indrect+ All Surface Access Polishers Intraoral, Acu-Flow, AdvantEdge and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Amalgamator, Dental, Ac-Powered | EFD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Applicator, Resin | KXR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cleanser, Denture, Prescription | NUX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Coating, Filling Material, Resin | EBD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Cord, Retraction | MVL | U | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Diagnostic Light, Soft Tissue Detector | NXV | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Disk, Abrasive | EHJ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Diamond, Dental | DZP | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Light, Examination, Medical, Battery Powered | KYT | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Loupe, Binocular, Low Power | HJH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Paper, Articulation | EFH | 1 | Complaint file establishment | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Point, Abrasive | EHL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Post, Root Canal | ELR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Scissors, Collar And Crown | EIR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Solution, Cement Dissolving | KZP | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Dental) | EIB | 1 | Specification developer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tip, Rubber, Oral Hygiene | JEW | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tray, Fluoride, Disposable | KMT | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Wheel, Polishing Agent | EJQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 25, 2025 | K251593 | DenMat Multilayered Zirconia Disc | EIH | Substantially Equivalent | Denmat Holding, LLC | accessdata.fda.gov |
| October 15, 2024 | K242097 | DenMat Bulk Fill Composite | EBF | Substantially Equivalent | Den-Mat Holdings, LLC | accessdata.fda.gov |
| April 27, 2023 | K223892 | DentMix VPS Impression Material | ELW | Substantially Equivalent | Innovative Product Brands, Inc. | accessdata.fda.gov |
| August 9, 2022 | K222357 | DenMat Glutaraldehyde Desensitizer | KLE | Substantially Equivalent | Denmat Holding, LLC | accessdata.fda.gov |
| March 24, 2017 | K162967 | nuance UNIVERSAL | EBF | Substantially Equivalent | Den-Mat Holdings, LLC | accessdata.fda.gov |
| May 1, 2015 | K143679 | Nuance FLOW | EBF | Substantially Equivalent | Den-Mat Holdings, LLC | accessdata.fda.gov |
| August 20, 2014 | K140537 | TENURE4G | KLE | Substantially Equivalent | Den-Mat Holdings, LLC | accessdata.fda.gov |
| July 25, 2014 | K141838 | SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL) | GEX | Substantially Equivalent | Regulatory Technology Services, LLC | accessdata.fda.gov |
| September 18, 2013 | K124025 | ALPHA-PRO WHITE VARNISH | LBH | Substantially Equivalent | Dental Technologies, Inc. | accessdata.fda.gov |
| December 27, 2012 | K122039 | KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B | EBG | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| September 21, 2011 | K111876 | Z BOND, PRELUDE ONE | KLE | Substantially Equivalent | Danville Materials, Inc. | accessdata.fda.gov |
| December 29, 2010 | K103667 | SAPPHIRE ST PORTABLE DIODE LASER | GEX | Substantially Equivalent | Den-Mat Holdings, LLC | accessdata.fda.gov |
| July 16, 2010 | K100752 | PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) | KLE | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| October 1, 2009 | K092539 | SEAMFREE | EBF | Substantially Equivalent | Apex Dental Materials, Inc. | accessdata.fda.gov |
| July 23, 2009 | K091894 | TEMPORARY C&B COMPOSITE | EBG | Substantially Equivalent | Voco GmbH | accessdata.fda.gov |
| January 23, 2009 | K082668 | BIO-SCREEN | NXV | Substantially Equivalent | Addent, Inc. | accessdata.fda.gov |
| January 15, 2009 | K082115 | PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT | EMA | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
| November 21, 2008 | K081287 | SAPPHIRE PLASMA ARC DENTAL CURING LIGHT | EBZ | Substantially Equivalent | Den-Mat Holdings, LLC | accessdata.fda.gov |
| August 4, 2008 | K081017 | TEMPLATE AND COUNTER-FIT | ELW | Substantially Equivalent | Clinician'S Choice Dental Products, Inc. | accessdata.fda.gov |
| May 14, 2008 | K081214 | STYLA MICROLASER AND STYLAORTHO | GEX | Substantially Equivalent | Zap Lasers, LLC | accessdata.fda.gov |
| May 1, 2008 | K081120 | FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS | ELW | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| April 4, 2008 | K080043 | VIZILITE EYEWEAR | NXV | Substantially Equivalent | Zila, Inc. | accessdata.fda.gov |
| December 20, 2007 | K073518 | FLASHLITE REBEL* | EBZ | Substantially Equivalent | Discus Dental, Inc. | accessdata.fda.gov |
| December 12, 2007 | K073005 | ELITE GLASS | ELW | Substantially Equivalent | Zhermack S.P.A. | accessdata.fda.gov |
| November 15, 2005 | K053014 | POLY SILOXANE IMPRESSION MATERIAL | ELW | Substantially Equivalent | Clinician'S Choice Dental Products, Inc. | accessdata.fda.gov |
| November 8, 2005 | K053018 | POLY SILOXANE IMPRESSION MATERIAL | ELW | Substantially Equivalent | Millennium Dental International, Inc. | accessdata.fda.gov |
| August 5, 2005 | K052090 | SPLASH! IMPRESSION MATERIAL DEVICE | ELW | Substantially Equivalent | Discus Dental, Inc. | accessdata.fda.gov |
| November 22, 2004 | K042614 | S&C-SELF ETCH PR-BOND | KLE | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
| November 22, 2004 | K033033 | VIZILITE-BLUE ORAL EXAM KIT | EAZ | Substantially Equivalent | Trylon Corp. | accessdata.fda.gov |
| April 7, 2004 | K040769 | STRUCTUR 2 SC | EBG | Substantially Equivalent | Voco GmbH | accessdata.fda.gov |
| March 25, 2004 | K040053 | PRECISION VPS IMPRESSION MATERIAL | ELW | Substantially Equivalent | Discus Dental, Inc. | accessdata.fda.gov |
| May 9, 2003 | K030776 | MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL | ELW | Substantially Equivalent | Discus Dental, Inc. | accessdata.fda.gov |
| January 17, 2003 | K023748 | FLASH-LITE II LED DENTAL CURING LIGHT | EBZ | Substantially Equivalent | Discus Dental, Inc. | accessdata.fda.gov |
| January 24, 2002 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | EBG | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| November 1, 2001 | K012767 | S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL | ELW | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
| September 14, 2001 | K010849 | VERTEX ETCHANT | EBF | Substantially Equivalent | Apex Dental Materials, Inc. | accessdata.fda.gov |
| November 2, 1999 | K992001 | TRAY-LINK | ELW | Substantially Equivalent | Silicon-Und Composite Spezialitaten GmbH | accessdata.fda.gov |
| March 9, 1999 | K990108 | LC FLOWFILL | EBF | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
| February 9, 1999 | K984097 | DC-CORE | EBF | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
| January 20, 1999 | K984484 | LC MICROHYBRID | EBF | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
| June 5, 1998 | K973201 | PROVI CEMENT | EMA | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
| April 22, 1997 | K964596 | PROSELECT 3 PERIDONTAL THERAPY SYSTEM | ELC | Substantially Equivalent | Professional Dental Mfg., Inc. | accessdata.fda.gov |
| October 3, 1995 | K953504 | MICROPRIME | KLE | Substantially Equivalent | Danville Engineering, Inc. | accessdata.fda.gov |
| March 31, 1995 | K951075 | S & C VINYL POLYSILOXANE IMPRESSION MATERIAL | ELW | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
| September 9, 1993 | K931867 | ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE | EBF | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| July 15, 1988 | K881918 | LIGHT-CURED ZIONOMER CEMENT | EMA | Substantially Equivalent | Den-Mat Corp. | accessdata.fda.gov |
| August 24, 1987 | K872510 | DEN-MAT TENURE | EBF | Substantially Equivalent | Den-Mat Corp. | accessdata.fda.gov |
| December 18, 1985 | K852630 | DEN-MAT PAINT-ON RUBBER DAM | EIE | Substantially Equivalent | Den-Mat Corp. | accessdata.fda.gov |
| March 30, 1984 | K841111 | REMBRANDT SHADE MODIFICATION KIT | EBF | Substantially Equivalent | Den-Mat Corp. | accessdata.fda.gov |
| June 17, 1980 | K801225 | DEN-MAT POLISHING PASTE | EJR | Substantially Equivalent | Den-Mat Corp. | accessdata.fda.gov |
| May 28, 1980 | K801216 | DEN-MAT DENTIN BONDING AGENT | KLE | Substantially Equivalent | Den-Mat Corp. | accessdata.fda.gov |
| January 12, 1978 | K771974 | SOLVENEX I-0 | KZP | Substantially Equivalent | Den-Mat Corp. | accessdata.fda.gov |
| January 3, 1978 | K772316 | MATRIX STRIP, DEAD-SOFT | DZN | Substantially Equivalent | Den-Mat Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 18, 2022 | 90031 | Class II | Terminated | Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912 | Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Tooth Shade, Resin
- All makers of Agent, Polishing, Abrasive, Oral Cavity
- All makers of Applicator, Resin
- All makers of Material, Impression
- All makers of Agent, Tooth Bonding, Resin
- All makers of Powered Laser Surgical Instrument
Updated August 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.