DeviceClearance

K130558

Substantially Equivalent

SOMNODENT HERBST; CLASSIC, FLEX

Applicant
Somnomed, Inc.
Product code
LRK
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Frisco, TX, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LRK

product code LRK
Injury
246
Malfunction
1,044
Total
1,290

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.