510k
Database
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Anesthesiology
527
Cardiovascular
1634
Chemistry
356
Dental
1304
Ear, Nose, Throat
239
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946
General & Plastic Surgery
2157
General Hospital
2020
Hematology
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
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
376
FXX
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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LuxCreo, Inc.
Medical Device Manufacturer
·
US , Belmont , CA
LuxCreo, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2022
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - LuxCreo, Inc.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 25, 2025
LuxCreo Flexible Partial Denture Resin
K253365
·
EBI
Dental
·
56d
Cleared
Apr 08, 2025
LuxCreo Clear Aligner System
K250343
·
NXC
Dental
·
61d
Cleared
Jan 18, 2024
LuxCreo Dental Night Guard Resin
K230592
·
MQC
Dental
·
321d
Cleared
May 31, 2022
LuxCreo Clear Aligner System
K212680
·
NXC
Dental
·
280d
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4
Dental
4