510k
Database
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Anesthesiology
527
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1634
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356
Dental
1304
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239
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946
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2157
General Hospital
2020
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126
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92
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8
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459
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948
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430
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272
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2795
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52
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515
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2368
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155
Categories
LZA
Polymer Patient Examination Glove
407
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System, Image Processing,...
376
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Mask, Surgical
357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
297
IYN
System, Imaging, Pulsed Doppler,...
276
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
220
NHA
Abutment, Implant, Dental,...
205
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Detax GmbH
Medical Device Manufacturer
·
DE , Ettingen
Detax GmbH - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2022
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Detax GmbH
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 30, 2025
Freeprint® denture flex
K252430
·
EBI
Dental
·
90d
Cleared
Oct 12, 2023
FREEPRINT® splintmaster
K232448
·
MQC
Dental
·
59d
Cleared
Sep 23, 2022
FREEPRINT crown
K222877
·
EBF
Dental
·
1d
Filters
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3
Dental
3