510k
Database
Specialties
Anesthesiology
139
Cardiovascular
574
Chemistry
167
Dental
321
Ear, Nose, Throat
68
Gastroenterology & Urology
293
General & Plastic Surgery
531
General Hospital
379
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
65
Ophthalmic
51
Orthopedic
1299
Pathology
18
Physical Medicine
88
Radiology
882
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
135
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Biocetec Co., Ltd.
Medical Device Manufacturer
·
KR , Seoul
Biocetec Co., Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2017
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Biocetec Co., Ltd.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 06, 2023
A-Line Advanced
K231635
·
NJM
Dental
·
1d
Cleared
Jan 17, 2020
Bio-TackS Orthodontic Mini Implant
K190871
·
OAT
Dental
·
289d
Cleared
Jan 22, 2019
S-Line
K182193
·
NJM
Dental
·
161d
Cleared
Jun 14, 2017
C-Line Orthodontic Ceramic Bracket
K163467
·
NJM
Dental
·
184d
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4
Dental
4