510k
Database
Specialties
Anesthesiology
198
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721
Chemistry
185
Dental
450
Ear, Nose, Throat
86
Gastroenterology & Urology
383
General & Plastic Surgery
751
General Hospital
460
Hematology
74
Immunology
61
Medical Genetics
1
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271
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288
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111
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75
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1464
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26
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146
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1068
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93
Categories
IYN
System, Imaging, Pulsed Doppler,...
162
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
128
LLZ
System, Image Processing,...
122
GEX
Powered Laser Surgical Instrument
122
QIH
Automated Radiological Image...
106
GEI
Electrosurgical, Cutting &...
104
NHA
Abutment, Implant, Dental,...
103
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Huge Dental Material Co., Ltd.
Medical Device Manufacturer
·
US , Dover , DE
Huge Dental Material Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2010
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Huge Dental Material Co., Ltd.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 03, 2020
PMMA Block
K201683
·
EBG
Dental
·
134d
Cleared
Aug 16, 2010
KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC...
K101029
·
ELM
Dental
·
125d
Filters
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2
Dental
2