Medical Device Manufacturer · US , Santa Maria , CA

Den-Mat Holdings, LLC - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2008

Recent clearances: MPa Max adhesive, DenMat Bulk Fill Composite, nuance UNIVERSAL

9
Total
9
Cleared
0
Denied

FDA 510(k) Regulatory Record - Den-Mat Holdings, LLC Dental ✕

7 devices
1-7 of 7
Cleared Sep 24, 2026
MPa Max adhesive
K262252 · KLE
Dental · 84d
Cleared Oct 15, 2024
DenMat Bulk Fill Composite
K242097 · EBF
Dental · 89d
Cleared Mar 24, 2017
nuance UNIVERSAL
K162967 · EBF
Dental · 151d
Cleared May 01, 2015
Nuance FLOW
K143679 · EBF
Dental · 128d
Cleared Aug 20, 2014
TENURE4G
K140537 · KLE
Dental · 169d
Cleared Nov 21, 2008
SAPPHIRE PLASMA ARC DENTAL CURING LIGHT
K081287 · EBZ
Dental · 198d
Cleared Apr 03, 2008
SAPPHIRE O/E ORAL EXAMINATION SYSTEM
K073483 · NXV
Dental · 114d
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