510k
Database
Specialties
Anesthesiology
133
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568
Chemistry
163
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
287
General & Plastic Surgery
514
General Hospital
371
Hematology
67
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56
Medical Genetics
0
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232
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164
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61
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49
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1291
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18
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85
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868
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Zentek Medical, LLC
Medical Device Manufacturer
·
US , Manalapan , NJ
Zentek Medical, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2022
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Zentek Medical, LLC
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 15, 2025
Bonafix Implant Abutments
K251294
·
NHA
Dental
·
173d
Cleared
Jul 14, 2023
Bonafix TiBase
K221673
·
NHA
Dental
·
400d
Cleared
Dec 20, 2022
Bonafix 2 Plus
K213677
·
DZE
Dental
·
393d
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3
Dental
3