CRYSTAL-BOND— 510(k) K810241

Substantially Equivalent

American Ormco

FDA 510(k) clearance K810241 for CRYSTAL-BOND, Substantially Equivalent on 1981-02-12. Applicant: American Ormco. Device class: 2.

Clearance details

Applicant: American Ormco
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 1981-01-28
Decision date: 1981-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, 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.