510k
Database
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Anesthesiology
207
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742
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187
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472
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92
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398
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783
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479
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77
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64
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1
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277
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309
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121
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81
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1483
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26
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155
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1102
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95
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IYN
System, Imaging, Pulsed Doppler,...
168
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Plate, Fixation, Bone
151
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Orthopedic Stereotaxic Instrument
131
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Powered Laser Surgical Instrument
128
LLZ
System, Image Processing,...
126
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Automated Radiological Image...
113
GEI
Electrosurgical, Cutting &...
105
NHA
Abutment, Implant, Dental,...
105
MAX
Intervertebral Fusion Device...
97
NKB
Thoracolumbosacral Pedicle Screw...
93
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Premier Dental Company Products
Medical Device Manufacturer
·
US , Plymouth Meeting , PA
Premier Dental Company Products - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2015
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Premier Dental Company Products
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 27, 2019
AeroPro Cordless Prophy System
K180682
·
EKX
Dental
·
349d
Cleared
Oct 18, 2016
Premier Sealant
K161580
·
EBC
Dental
·
132d
Cleared
Jul 22, 2015
Zeramic Adhesive Resin Cement
K150601
·
EMA
Dental
·
134d
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3
Dental
3