PALASEAL(R)— 510(k) K892452

Name: FDA 510(k) clearance K892452
Creator: U.S. Food and Drug Administration
Published: 1989-06-16

Substantially Equivalent

Kulzer, Inc.

FDA 510(k) clearance K892452 for PALASEAL(R), Substantially Equivalent on 1989-06-16. Applicant: Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Kulzer, Inc.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 1989-04-10
Decision date: 1989-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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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.