ZINC PHOSPHATE CEMENT— 510(k) K983018

Substantially Equivalent

Medental Intl.

FDA 510(k) clearance K983018 for ZINC PHOSPHATE CEMENT, Substantially Equivalent on 1998-10-22. Applicant: Medental Intl.. Device class: 2.

Clearance details

Applicant: Medental Intl.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1998-08-28
Decision date: 1998-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Evergreen, CO, 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.