MODIFICATION TO LINER II: SOFT RELINE LIQUID— 510(k) K991687

Substantially Equivalent

Bosworth Co.

FDA 510(k) clearance K991687 for MODIFICATION TO LINER II: SOFT RELINE LIQUID, Substantially Equivalent on 1999-10-07. Applicant: Bosworth Co..

Clearance details

Applicant: Bosworth Co.
Product code: Code EBI
Advisory panel: Dental
Date received: 1999-05-17
Decision date: 1999-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, US

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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.