AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL— 510(k) K863630

Name: FDA 510(k) clearance K863630
Creator: U.S. Food and Drug Administration
Published: 1987-03-11

Substantially Equivalent

Austenal Dental, Inc.

FDA 510(k) clearance K863630 for AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL, Substantially Equivalent on 1987-03-11. Applicant: Austenal Dental, Inc.. Device class: 2.

Clearance details

Applicant: Austenal Dental, Inc.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 1986-09-17
Decision date: 1987-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Austenal Dental, Inc.

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K890713 — OVERDENTURE - STUD ATTACHMENT1989-07-14
K883799 — BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN1988-10-20
K880875 — VITALLIUM EQUIPOISE ALLOY1988-04-07
K871849 — LIGHT CURE DENTURE GLAZE1987-08-10
K872746 — VITALLIUM WIRE1987-07-21

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.