510k
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540
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362
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1335
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245
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2043
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126
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97
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466
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433
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2900
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52
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515
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2433
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155
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Polymer Patient Examination Glove
408
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386
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358
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356
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302
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296
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Automated Radiological Image...
276
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Plate, Fixation, Bone
270
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Orthopedic Stereotaxic Instrument
227
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Intervertebral Fusion Device...
219
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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) Regulatory Record - 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