SILICONE IMPRESSION MATERIAL— 510(k) K011450

Name: FDA 510(k) clearance K011450
Creator: U.S. Food and Drug Administration
Published: 2001-06-13

Substantially Equivalent

Northeast Resins & Silicones, LLC

FDA 510(k) clearance K011450 for SILICONE IMPRESSION MATERIAL, Substantially Equivalent on 2001-06-13. Applicant: Northeast Resins & Silicones, LLC. Device class: 2.

Clearance details

Applicant: Northeast Resins & Silicones, LLC
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2001-05-11
Decision date: 2001-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheshire, CT, US

Download summary PDF View on FDA.gov ↗

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