POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)— 510(k) K945142

Name: FDA 510(k) clearance K945142
Creator: U.S. Food and Drug Administration
Published: 1995-01-11

Substantially Equivalent

Scican

FDA 510(k) clearance K945142 for POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL), Substantially Equivalent on 1995-01-11. Applicant: Scican. Device class: 2.

Clearance details

Applicant: Scican
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1994-10-20
Decision date: 1995-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.