REIGNING EPOXY RESIN CEMENT— 510(k) K801236

Name: FDA 510(k) clearance K801236
Creator: U.S. Food and Drug Administration
Published: 1980-07-08

Substantially Equivalent

Oki Shiks USA , Ltd.

FDA 510(k) clearance K801236 for REIGNING EPOXY RESIN CEMENT, Substantially Equivalent on 1980-07-08. Applicant: Oki Shiks USA , Ltd.. Device class: 2.

Clearance details

Applicant: Oki Shiks USA , Ltd.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1980-05-27
Decision date: 1980-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.