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10089
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2829
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7851
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14198
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2657
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894
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3131
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12910
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Powered Laser Surgical Instrument
2430
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System, Image Processing,...
2060
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1942
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Implant, Endosseous, Root-form
1331
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1287
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Laparoscope, General & Plastic...
1140
IYN
System, Imaging, Pulsed Doppler,...
1136
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Polymer Patient Examination Glove
1091
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System, Nuclear Magnetic...
1003
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Screw, Fixation, Bone
990
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510k Database
Manufacturers
SE
Astra Meditec AB
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Medical Device Manufacturer
·
SE , Sweden
Astra Meditec AB - FDA 510(k) Cleared Devices
3 submissions
·
2 cleared
·
Since 1988
3
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Astra Meditec AB
Dental
✕
1
devices
1-1 of 1
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Cleared
Aug 12, 1988
ASTRA DENTAL IMPLANT SYSTEM
K882578
·
DZE
Dental
·
51d
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3
Dental
1
Gastroenterology & Urology
1
General & Plastic Surgery
1