TOKUYAMA REBASE II— 510(k) K022641

Name: FDA 510(k) clearance K022641
Creator: U.S. Food and Drug Administration
Published: 2002-10-02

Substantially Equivalent

Tokuyama America, Inc.

FDA 510(k) clearance K022641 for TOKUYAMA REBASE II, Substantially Equivalent on 2002-10-02. Applicant: Tokuyama America, Inc.. Device class: 2.

Clearance details

Applicant: Tokuyama America, Inc.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2002-08-08
Decision date: 2002-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K993917 — TOKUYAMA ONE-UP-BOND F2000-02-02

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.