510k
Database
Specialties
Anesthesiology
569
Cardiovascular
1783
Chemistry
394
Dental
1443
Ear, Nose, Throat
262
Gastroenterology & Urology
1026
General & Plastic Surgery
2311
General Hospital
2141
Hematology
133
Immunology
106
Medical Genetics
8
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483
Neurology
1033
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473
Ophthalmic
302
Orthopedic
3170
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52
Physical Medicine
530
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2593
Toxicology
159
Categories
LZA
Polymer Patient Examination Glove
428
LLZ
System, Image Processing,...
413
GEX
Powered Laser Surgical Instrument
378
FXX
Mask, Surgical
363
GEI
Electrosurgical, Cutting &...
326
IYN
System, Imaging, Pulsed Doppler,...
310
HRS
Plate, Fixation, Bone
302
QIH
Automated Radiological Image...
280
OLO
Orthopedic Stereotaxic Instrument
246
MAX
Intervertebral Fusion Device...
245
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Manufacturers
US
Star Dental Mfg. Co.
Medical Device Manufacturer
·
US , Mchenry , IL
Star Dental Mfg. Co. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1977
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Star Dental Mfg. Co.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Feb 13, 1991
HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES
K905155
·
EFB
Dental
·
90d
Cleared
Jan 03, 1979
ROTARY SCALER
K782007
·
ELB
Dental
·
33d
Cleared
Aug 21, 1978
CEMENT, DENTAL/CAVITY LINER
K781281
·
EMA
Dental
·
26d
Cleared
Jul 15, 1977
CORE MATERIAL
K771247
·
EBF
Dental
·
4d
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5
Dental
4
Anesthesiology
1