DeviceClearance

K001463

Substantially Equivalent

SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156

Applicant
Davis Schottlander & Davis, Ltd.
Product code
EBI
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Kansas City, MO, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code EBI

product code EBI
Other
1
Total
1

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.