POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT— 510(k) K030727

Name: FDA 510(k) clearance K030727
Creator: U.S. Food and Drug Administration
Published: 2003-06-05

Substantially Equivalent

Healex Products, Inc.

FDA 510(k) clearance K030727 for POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT, Substantially Equivalent on 2003-06-05. Applicant: Healex Products, Inc.. Device class: 2.

Clearance details

Applicant: Healex Products, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2003-03-07
Decision date: 2003-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Providence, RI, US

Download summary PDF View on FDA.gov ↗

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