HY BOND, GLASIONOMER CX— 510(k) K940122

Substantially Equivalent

Shofu Dental Corp.

FDA 510(k) clearance K940122 for HY BOND, GLASIONOMER CX, Substantially Equivalent on 1994-05-02. Applicant: Shofu Dental Corp.. Device class: 2.

Clearance details

Applicant: Shofu Dental Corp.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1994-01-10
Decision date: 1994-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, 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.