510k
Database
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Anesthesiology
540
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1660
Chemistry
362
Dental
1329
Ear, Nose, Throat
244
Gastroenterology & Urology
957
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2182
General Hospital
2039
Hematology
126
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97
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8
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464
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962
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433
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274
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2862
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52
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515
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2418
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Nobel Biocare Services AG
Medical Device Manufacturer
·
CH , Kloten
Nobel Biocare Services AG - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2021
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nobel Biocare Services AG
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 16, 2022
Esthetic Abutments Nobel Biocare N1
K220339
·
NHA
Dental
·
221d
Cleared
Jul 29, 2022
NobelProcera Zirconia N1 Base
K220048
·
NHA
Dental
·
204d
Cleared
Dec 21, 2021
N1 TiUltra TCC Implant System
K211109
·
DZE
Dental
·
251d
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5
Dental
3
General Hospital
2