510k
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957
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3333
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1106
Dental
2069
Ear, Nose, Throat
376
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1877
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3437
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3337
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288
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247
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15
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1044
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1555
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734
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469
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4905
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80
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674
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4118
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336
Categories
LLZ
System, Image Processing,...
701
GEX
Powered Laser Surgical Instrument
510
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System, Imaging, Pulsed Doppler,...
501
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Electrosurgical, Cutting &...
489
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Polymer Patient Examination Glove
483
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Plate, Fixation, Bone
435
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Intervertebral Fusion Device...
403
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Mask, Surgical
391
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System, Nuclear Magnetic...
345
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Thoracolumbosacral Pedicle Screw...
343
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Manufacturers
US
Dental Arte, Inc.
Medical Device Manufacturer
·
US , Poway , CA
Dental Arte, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2006
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dental Arte, Inc.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 08, 2011
BRUX MOUTHGUARDS
K111310
·
OBR
Dental
·
212d
Cleared
Mar 03, 2006
FENIIIIIIX COLORATION KIT
K060086
·
EIH
Dental
·
51d
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Dental
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