STERNVANTAGE VARNISH LC, MODEL 221001— 510(k) K984341

Substantially Equivalent

Sterngold/Implamed

FDA 510(k) clearance K984341 for STERNVANTAGE VARNISH LC, MODEL 221001, Substantially Equivalent on 1999-01-08. Applicant: Sterngold/Implamed.

Clearance details

Applicant: Sterngold/Implamed
Product code: Code EBI
Advisory panel: Dental
Date received: 1998-12-04
Decision date: 1999-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Attleboro, MA, 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.