510k
Database
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550
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1723
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386
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1390
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256
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990
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2232
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2093
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127
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104
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8
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474
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985
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443
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286
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3064
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52
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515
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2505
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156
Categories
LZA
Polymer Patient Examination Glove
418
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System, Image Processing,...
401
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Powered Laser Surgical Instrument
365
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359
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310
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System, Imaging, Pulsed Doppler,...
305
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Plate, Fixation, Bone
298
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Automated Radiological Image...
277
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Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
234
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Denterprise International, Inc.
Medical Device Manufacturer
·
US , Ormond Beach , FL
Denterprise International, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2012
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Denterprise International, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 22, 2023
QuickRayPRO
K231202
·
MUH
Radiology
·
56d
Cleared
Apr 04, 2018
MobileX Portable X-ray System
K180561
·
EHD
Radiology
·
30d
Cleared
Dec 14, 2015
QuickRay HD Intraoral Sensor
K151926
·
MUH
Radiology
·
153d
Cleared
Dec 07, 2012
DENTAL X-RAY Z70 (W)
K122582
·
EHD
Radiology
·
106d
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4
Radiology
4