ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND— 510(k) K921044

Name: FDA 510(k) clearance K921044
Creator: U.S. Food and Drug Administration
Published: 1992-11-09

Substantially Equivalent

Wallace A. Erickson & Co.

FDA 510(k) clearance K921044 for ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND, Substantially Equivalent on 1992-11-09. Applicant: Wallace A. Erickson & Co.. Device class: 2.

Clearance details

Applicant: Wallace A. Erickson & Co.
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 1992-03-04
Decision date: 1992-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, 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.