AUSTENAL MODIFIED ACRYLIC DENTURE RESIN— 510(k) K853160

Name: FDA 510(k) clearance K853160
Creator: U.S. Food and Drug Administration
Published: 1985-10-31

Substantially Equivalent

Austenal Dental, Inc.

FDA 510(k) clearance K853160 for AUSTENAL MODIFIED ACRYLIC DENTURE RESIN, Substantially Equivalent on 1985-10-31. Applicant: Austenal Dental, Inc.. Device class: 2.

Clearance details

Applicant: Austenal Dental, Inc.
Product code: Code ELM
Device class: Class 2
Regulation: 21 CFR 872.3590
Advisory panel: Dental
Date received: 1985-07-30
Decision date: 1985-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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