510k
Database
Specialties
Anesthesiology
6500
Cardiovascular
15016
Chemistry
11353
Dental
10106
Ear, Nose, Throat
2830
Gastroenterology & Urology
7863
General & Plastic Surgery
14217
General Hospital
12305
Hematology
2657
Immunology
3165
Medical Genetics
20
Microbiology
5997
Neurology
4894
Obstetrics & Gynecology
3322
Ophthalmic
3039
Orthopedic
16889
Pathology
894
Physical Medicine
3140
Radiology
12931
Toxicology
2660
Categories
GEX
Powered Laser Surgical Instrument
2434
LLZ
System, Image Processing,...
2066
GEI
Electrosurgical, Cutting &...
1945
DZE
Implant, Endosseous, Root-form
1331
HRS
Plate, Fixation, Bone
1291
GCJ
Laparoscope, General & Plastic...
1142
IYN
System, Imaging, Pulsed Doppler,...
1139
LZA
Polymer Patient Examination Glove
1093
LNH
System, Nuclear Magnetic...
1003
HWC
Screw, Fixation, Bone
992
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
Otc/America
Share
Medical Device Manufacturer
·
US , Wellesley Hills , MA
Otc/America - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1986
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Otc/America
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 07, 1986
OSSEODENT DRILLING SYSTEM
K862110
·
KMW
Dental
·
65d
Cleared
Apr 17, 1986
PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT
K860653
·
DZE
Dental
·
55d
Filters
Filter by Specialty
All
2
Dental
2