510k
Database
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Anesthesiology
425
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1284
Chemistry
315
Dental
972
Ear, Nose, Throat
184
Gastroenterology & Urology
754
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1647
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1054
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114
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82
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6
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407
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715
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315
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193
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2322
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43
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385
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1867
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139
Categories
GEX
Powered Laser Surgical Instrument
275
LLZ
System, Image Processing,...
260
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Automated Radiological Image...
243
IYN
System, Imaging, Pulsed Doppler,...
230
HRS
Plate, Fixation, Bone
229
GEI
Electrosurgical, Cutting &...
228
OLO
Orthopedic Stereotaxic Instrument
190
NHA
Abutment, Implant, Dental,...
177
LZA
Polymer Patient Examination Glove
160
NKB
Thoracolumbosacral Pedicle Screw...
158
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Dentamerica
Medical Device Manufacturer
·
US , Industry , CA
Dentamerica - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1996
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dentamerica
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 07, 2010
ENDOMAX CORDLESS ENDODONTIC HANDPIECE
K092833
·
EKX
Dental
·
114d
Cleared
Jan 18, 1996
SCALEX 800
K954820
·
ELC
Dental
·
90d
Cleared
Jan 02, 1996
LITEX 680
K955759
·
EBZ
Dental
·
15d
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4
Dental
3
Radiology
1