DeviceClearance

K072425

Substantially Equivalent

JNE IMPLANT SYSTEM

Applicant
GC America, Inc.
Product code
DZE
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Lake Forest, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DZE

product code DZE
Death
28
Injury
3,367,041
Malfunction
19,958
Other
13
Total
3,387,040

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.