SOCK IT! ORAL PAIN GEL— 510(k) K063148

Substantially Equivalent

Merlin Group Dba Mcmerlin Dental Company

FDA 510(k) clearance K063148 for SOCK IT! ORAL PAIN GEL, Substantially Equivalent on 2007-01-17. Applicant: Merlin Group Dba Mcmerlin Dental Company.

Clearance details

Applicant
Merlin Group Dba Mcmerlin Dental Company
Product code
Code OLR
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Grand Prairie, TX, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code OLR

product code OLR
Death
3
Total
3

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.