510k
Database
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652
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1970
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432
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1601
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284
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142
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112
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3441
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57
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556
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2824
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457
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Polymer Patient Examination Glove
434
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403
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384
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359
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System, Imaging, Pulsed Doppler,...
347
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317
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284
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Intervertebral Fusion Device...
266
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Orthopedic Stereotaxic Instrument
262
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Manufacturers
US
Dmetec.Co., Ltd.
Medical Device Manufacturer
·
US , Great Neck , NY
Dmetec.Co., Ltd. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2005
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dmetec.Co., Ltd.
Dental
✕
5
devices
1-5 of 5
Filters
Cleared
Dec 27, 2017
COMPACT S, COMPACT S (LED)
K170104
·
ELC
Dental
·
349d
Cleared
Dec 11, 2012
ULTRASONIC SURGERY
K121620
·
DZI
Dental
·
193d
Cleared
Jun 14, 2012
ULTRASONIC SURGERY MACHINE
K113152
·
DZI
Dental
·
233d
Cleared
Mar 29, 2006
CLEANSE S+ ULTRASONIC SCALER
K060171
·
ELC
Dental
·
65d
Cleared
Jul 19, 2005
SKYLIGHT LED CURING LIGHT
K051571
·
EBZ
Dental
·
35d
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5
Dental
5