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522
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490
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510k Database
Manufacturers
US
Open Implants, LLC
Medical Device Manufacturer
·
US , Woburn , MA
Open Implants, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2020
Recent clearances:
Sherlock
,
Sherlock
,
Sherlock
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Open Implants, LLC
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 26, 2025
Sherlock
K250967
·
NHA
Dental
·
87d
Cleared
Jun 21, 2022
Sherlock
K220482
·
NHA
Dental
·
123d
Cleared
Nov 30, 2021
Sherlock
K212664
·
NHA
Dental
·
99d
Cleared
Mar 24, 2020
Sherlock
K193335
·
NHA
Dental
·
113d
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4
Dental
4