DENOPTIX BARRIER ENVELOPE (SIZE 0-4)— 510(k) K980543

Name: FDA 510(k) clearance K980543
Creator: U.S. Food and Drug Administration
Published: 1998-04-14

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K980543 for DENOPTIX BARRIER ENVELOPE (SIZE 0-4), Substantially Equivalent on 1998-04-14. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 1998-02-12
Decision date: 1998-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, 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.