510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1612
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
928
General & Plastic Surgery
2135
General Hospital
1991
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
942
Obstetrics & Gynecology
429
Ophthalmic
272
Orthopedic
2704
Pathology
52
Physical Medicine
515
Radiology
2334
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
370
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
266
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Medical Device Manufacturer
·
CN , Shenzhen
SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 16, 2025
Alpha Endo Handpiece (Alpha Endo)
K252223
·
EKX
Dental
·
92d
Cleared
Jan 17, 2025
Electronic Apex Locator (Alpha Apex I)
K242765
·
LQY
Dental
·
126d
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2
Dental
2