POLYVINYL SILICONE IMPRESSION MATERIAL— 510(k) K810825

Name: FDA 510(k) clearance K810825
Creator: U.S. Food and Drug Administration
Published: 1981-04-14

Substantially Equivalent

Dental-Material Gesellschaft

FDA 510(k) clearance K810825 for POLYVINYL SILICONE IMPRESSION MATERIAL, Substantially Equivalent on 1981-04-14. Applicant: Dental-Material Gesellschaft. Device class: 2.

Clearance details

Applicant: Dental-Material Gesellschaft
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1981-03-24
Decision date: 1981-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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