510k
Database
Specialties
Anesthesiology
338
Cardiovascular
1073
Chemistry
272
Dental
822
Ear, Nose, Throat
149
Gastroenterology & Urology
637
General & Plastic Surgery
1338
General Hospital
770
Hematology
100
Immunology
72
Medical Genetics
1
Microbiology
367
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589
Obstetrics & Gynecology
247
Ophthalmic
155
Orthopedic
2063
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40
Physical Medicine
311
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1591
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
231
HRS
Plate, Fixation, Bone
211
IYN
System, Imaging, Pulsed Doppler,...
209
QIH
Automated Radiological Image...
208
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
186
OLO
Orthopedic Stereotaxic Instrument
170
NHA
Abutment, Implant, Dental,...
161
NKB
Thoracolumbosacral Pedicle Screw...
138
MAX
Intervertebral Fusion Device...
138
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Premier Dental Products Company
Medical Device Manufacturer
·
US , Plymouth Meeting , PA
Premier Dental Products Company - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2022
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Premier Dental Products Company
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 03, 2026
Bond-PR™ Universal Adhesive
K260682
·
KLE
Dental
·
1d
Cleared
Nov 07, 2025
MultiMatch Flow Chameleon AntiMicrobial Composite
K253513
·
EBF
Dental
·
1d
Cleared
Dec 06, 2022
Premier's MultiMatch Universal Chameleon Restorative Composite
K223632
·
EBF
Dental
·
1d
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3
Dental
3