ClearanceBrief
Company ยท US

Den-Mat Holdings, LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.

9510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
EBFMaterial, Tooth Shade, Resin3
GEXPowered Laser Surgical Instrument2
KLEAgent, Tooth Bonding, Resin2
EBZActivator, Ultraviolet, For Polymerization1
NXVDiagnostic Light, Soft Tissue Detector1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 24, 2026K262252MPa Max adhesive
Den-Mat Holdings, LLC
KLE
Oct 15, 2024K242097DenMat Bulk Fill Composite
Den-Mat Holdings, LLC
EBF
Mar 24, 2017K162967nuance UNIVERSAL
Den-Mat Holdings, LLC
EBF
May 1, 2015K143679Nuance FLOW
Den-Mat Holdings, LLC
EBF
Aug 20, 2014K140537TENURE4G
Den-Mat Holdings, LLC
KLE
Feb 10, 2011K110079SPPHINE PLUS STM 3W DIODE LASER
Den-Mat Holdings, LLC
GEX
Dec 29, 2010K103667SAPPHIRE ST PORTABLE DIODE LASER
Den-Mat Holdings, LLC
GEX
Nov 21, 2008K081287SAPPHIRE PLASMA ARC DENTAL CURING LIGHT
Den-Mat Holdings, LLC
EBZ
Apr 3, 2008K073483SAPPHIRE O/E ORAL EXAMINATION SYSTEM
Den-Mat Holdings, LLC
NXV

Latest recalls

DateFirm and productCodeLinked 510(k)
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