510k
Database
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Anesthesiology
130
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566
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162
Dental
310
Ear, Nose, Throat
68
Gastroenterology & Urology
286
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512
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370
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67
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56
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0
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232
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163
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61
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49
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1288
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18
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85
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866
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
84
NHA
Abutment, Implant, Dental,...
83
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Dentalmax Co., Ltd.
Medical Device Manufacturer
·
KR , Cheonan-Si
Dentalmax Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2018
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Dentalmax Co., Ltd.
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 30, 2024
LUXEN 5G
K241151
·
EIH
Dental
·
158d
Cleared
Dec 06, 2021
LUXEN CL Dental Liquid
K212548
·
EIH
Dental
·
115d
Cleared
Oct 31, 2018
LUXEN Zr, LUXEN Smile
K171585
·
EIH
Dental
·
518d
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3
Dental
3