TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS— 510(k) K924645

Name: FDA 510(k) clearance K924645
Creator: U.S. Food and Drug Administration
Published: 1992-11-25

Substantially Equivalent

Unitek Corp.

FDA 510(k) clearance K924645 for TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS, Substantially Equivalent on 1992-11-25. Applicant: Unitek Corp.. Device class: 1.

Clearance details

Applicant: Unitek Corp.
Product code: Code JEX
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1992-09-14
Decision date: 1992-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, CA, 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.