510k
Database
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540
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1672
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362
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1335
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245
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964
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2190
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2043
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126
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97
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8
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466
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433
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274
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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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System, Image Processing,...
386
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358
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Powered Laser Surgical Instrument
356
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302
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System, Imaging, Pulsed Doppler,...
296
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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S.I.N. Implant System Ltda
Medical Device Manufacturer
·
BR , S?o Paulo
S.I.N. Implant System Ltda - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2025
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - S.I.N. Implant System Ltda
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 07, 2025
S.I.N. Tapered Pro Conical Zygoma Implant System
K251129
·
DZE
Dental
·
210d
Cleared
Oct 17, 2025
S.I.N. Dental Implant System
K252266
·
NHA
Dental
·
88d
Cleared
Sep 26, 2025
S.I.N. Dental Implant System
K251262
·
DZE
Dental
·
156d
Cleared
Aug 13, 2025
S.I.N. Dental Implant System
K251046
·
DZE
Dental
·
132d
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4
Dental
4