Den-Mat Holdings, LLC
Lompoc, CA, US
DEN-MAT HOLDINGS, LLC appears in FDA device records in Lompoc, CA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Den-Mat Holdings, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Clinician'S Choice Dental Products, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 10 510(k) clearances for Den-Mat Holdings, LLC between 2005 and 2024. The busiest year on record is 2008, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2008 | 3 |
| 2010 | 1 |
| 2011 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242097 | DenMat Bulk Fill Composite | EBF | Substantially Equivalent | |
| K162967 | nuance UNIVERSAL | EBF | Substantially Equivalent | |
| K143679 | Nuance FLOW | EBF | Substantially Equivalent | |
| K140537 | TENURE4G | KLE | Substantially Equivalent | |
| K110079 | SPPHINE PLUS STM 3W DIODE LASER | GEX | Substantially Equivalent | |
| K103667 | SAPPHIRE ST PORTABLE DIODE LASER | GEX | Substantially Equivalent | |
| K081287 | SAPPHIRE PLASMA ARC DENTAL CURING LIGHT | EBZ | Substantially Equivalent | |
| K081017 | TEMPLATE AND COUNTER-FIT | ELW | Substantially Equivalent | |
| K073483 | SAPPHIRE O/E ORAL EXAMINATION SYSTEM | NXV | Substantially Equivalent | |
| K053014 | POLY SILOXANE IMPRESSION MATERIAL | ELW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2018957 | 2018957 | DEN-MAT HOLDINGS, LLC | 1017 W Central Ave, Lompoc, CA 93436 US | 2026 | and 32 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EBZActivator, Ultraviolet, For Polymerization
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KLEAgent, Tooth Bonding, Resin
- EFDAmalgamator, Dental, Ac-Powered
- KXRApplicator, Resin
- EJLBur, Dental
- EMACement, Dental
- NUXCleanser, Denture, Prescription
- EBDCoating, Filling Material, Resin
- MVLCord, Retraction
- EBGCrown And Bridge, Temporary, Resin
- EIEDam, Rubber
- NXVDiagnostic Light, Soft Tissue Detector
- EHJDisk, Abrasive
- EJBHandle, Instrument, Dental
- DZPInstrument, Diamond, Dental
- DZNInstruments, Dental Hand
- KYTLight, Examination, Medical, Battery Powered
- EAZLight, Operating, Dental
- HJHLoupe, Binocular, Low Power
- ELWMaterial, Impression
- EBFMaterial, Tooth Shade, Resin
- EFHPaper, Articulation
- JETPick, Massaging
- JEXPlier, Orthodontic
- EHLPoint, Abrasive
- ELRPost, Root Canal
- EIHPowder, Porcelain
- GEXPowered Laser Surgical Instrument
- ELCScaler, Ultrasonic
- EIRScissors, Collar And Crown
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- KZPSolution, Cement Dissolving
- EIBSyringe, Irrigating (Dental)
- EIDSyringe, Restorative And Impression Material
- JEWTip, Rubber, Oral Hygiene
- JEQToothbrush, Powered
- KMTTray, Fluoride, Disposable
- EHYTray, Impression, Preformed
- LBHVarnish, Cavity
- EJQWheel, Polishing Agent
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1100-2022 | 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 | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain