POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)— 510(k) K954976

Name: FDA 510(k) clearance K954976
Creator: U.S. Food and Drug Administration
Published: 1996-04-25

Substantially Equivalent

Healex Products, Inc.

FDA 510(k) clearance K954976 for POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION), Substantially Equivalent on 1996-04-25. Applicant: Healex Products, Inc.. Device class: 2.

Clearance details

Applicant: Healex Products, Inc.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 1995-10-27
Decision date: 1996-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Providence, RI, 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.