510k
Database
Specialties
Anesthesiology
541
Cardiovascular
1672
Chemistry
364
Dental
1336
Ear, Nose, Throat
245
Gastroenterology & Urology
969
General & Plastic Surgery
2190
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2046
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126
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97
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8
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466
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965
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433
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274
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2912
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52
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515
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2433
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155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Zirkonzahn Srl
Medical Device Manufacturer
·
US , Silver Creek , NY
Zirkonzahn Srl - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 2014
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Zirkonzahn Srl
Radiology
✕
1
devices
1-1 of 1
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Cleared
Jul 20, 2021
ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL...
K203765
·
LLZ
Radiology
·
209d
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8
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7
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1