510k
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Anesthesiology
538
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1656
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360
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1323
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243
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957
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2176
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2038
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126
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97
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8
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462
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959
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433
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274
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2838
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52
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515
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2413
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
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Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
213
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Denmat Holding, LLC
Medical Device Manufacturer
·
US , Lompoc , CA
Denmat Holding, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2022
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Denmat Holding, LLC
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 25, 2025
DenMat Multilayered Zirconia Disc
K251593
·
EIH
Dental
·
90d
Cleared
Aug 09, 2022
DenMat Glutaraldehyde Desensitizer
K222357
·
KLE
Dental
·
5d
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2
Dental
2