KOOLINER II— 510(k) K935261

Substantially Equivalent

GC America, Inc.

FDA 510(k) clearance K935261 for KOOLINER II, Substantially Equivalent on 1994-01-26. Applicant: GC America, Inc..

Clearance details

Applicant: GC America, Inc.
Product code: Code EBI
Advisory panel: Dental
Date received: 1993-11-03
Decision date: 1994-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alsip, IL, 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, 2020-01-01 through 2026-04-23. 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.