SILICONE SPLINTING MATERIAL— 510(k) K840113

Name: FDA 510(k) clearance K840113
Creator: U.S. Food and Drug Administration
Published: 1985-04-17

Substantially Equivalent

General Dental Products, Inc.

FDA 510(k) clearance K840113 for SILICONE SPLINTING MATERIAL, Substantially Equivalent on 1985-04-17. Applicant: General Dental Products, Inc.. Device class: 1.

Clearance details

Applicant: General Dental Products, Inc.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 1984-01-11
Decision date: 1985-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elk Grove Village, IL, US

Download summary PDF View on FDA.gov ↗

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