AUSTENAL ACUPAC HI DENTURE BASE MATERIAL— 510(k) K862558

Substantially Equivalent

Austenal Dental, Inc.

FDA 510(k) clearance K862558 for AUSTENAL ACUPAC HI DENTURE BASE MATERIAL, Substantially Equivalent on 1986-07-18. Applicant: Austenal Dental, Inc..

Clearance details

Applicant: Austenal Dental, Inc.
Product code: Code EBI
Advisory panel: Dental
Date received: 1986-07-03
Decision date: 1986-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, 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.