510k
Database
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Anesthesiology
1274
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4660
Chemistry
3348
Dental
2796
Ear, Nose, Throat
474
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2457
General & Plastic Surgery
4191
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3861
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808
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796
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15
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1914
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1779
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890
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497
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7961
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167
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964
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4789
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1242
Categories
LLZ
System, Image Processing,...
730
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Plate, Fixation, Bone
696
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Electrosurgical, Cutting &...
570
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System, Imaging, Pulsed Doppler,...
535
GEX
Powered Laser Surgical Instrument
523
JWH
Prosthesis, Knee,...
517
LZA
Polymer Patient Examination Glove
489
LNH
System, Nuclear Magnetic...
431
MAX
Intervertebral Fusion Device...
418
HWC
Screw, Fixation, Bone
402
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Manufacturers
IL
Deldent , Ltd.
Medical Device Manufacturer
·
IL , Petach Tikvah
Deldent , Ltd. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2001
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Deldent , Ltd.
Dental
✕
6
devices
1-6 of 6
Filters
Cleared
Feb 19, 2002
JETPOLISHER
K014249
·
KOJ
Dental
·
55d
Cleared
Feb 19, 2002
JETSTREAM
K014252
·
KOJ
Dental
·
55d
Cleared
Jan 29, 2002
JETSONIC 2000
K014245
·
KOJ
Dental
·
34d
Cleared
Jan 24, 2002
DELSONIC 2000
K014238
·
ELC
Dental
·
29d
Cleared
Jan 10, 2002
MINIBLASTER
K013969
·
KOJ
Dental
·
38d
Cleared
Jun 05, 2001
DELDENT ULTRASONIC INSERTS
K011179
·
ELC
Dental
·
49d
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6
Dental
6