ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT)— 510(k) K933543

Name: FDA 510(k) clearance K933543
Creator: U.S. Food and Drug Administration
Published: 1993-11-01

Substantially Equivalent

Jedental Co., Inc.

FDA 510(k) clearance K933543 for ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT), Substantially Equivalent on 1993-11-01. Applicant: Jedental Co., Inc.. Device class: 2.

Clearance details

Applicant: Jedental Co., Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1993-07-20
Decision date: 1993-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southampton, PA, US

Download summary PDF View on FDA.gov ↗

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