FIXTECTOR— 510(k) K864572

Substantially Equivalent

Prodent Intl., Inc.

FDA 510(k) clearance K864572 for FIXTECTOR, Substantially Equivalent on 1987-02-12. Applicant: Prodent Intl., Inc.. Device class: 1.

Clearance details

Applicant: Prodent Intl., Inc.
Product code: Code EFH
Device class: Class 1
Regulation: 21 CFR 872.6140
Advisory panel: Dental
Date received: 1986-11-20
Decision date: 1987-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alexandria, VA, 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.