510k
Database
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204
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737
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187
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465
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91
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393
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770
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475
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77
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64
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277
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116
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77
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1476
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26
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152
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1085
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93
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IYN
System, Imaging, Pulsed Doppler,...
167
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Plate, Fixation, Bone
151
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Orthopedic Stereotaxic Instrument
130
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Powered Laser Surgical Instrument
125
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System, Image Processing,...
123
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Automated Radiological Image...
109
NHA
Abutment, Implant, Dental,...
105
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Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
96
NKB
Thoracolumbosacral Pedicle Screw...
93
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Oralabs, Inc.
Medical Device Manufacturer
·
US , Parker , CO
Oralabs, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2012
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Oralabs, Inc.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 21, 2019
CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray
K181839
·
LFD
Dental
·
498d
Cleared
Jun 27, 2012
ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD
K113326
·
OBR
Dental
·
230d
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2
Dental
2