BANDTITE GLASS IONOMER CEMENT— 510(k) K896249

Name: FDA 510(k) clearance K896249
Creator: U.S. Food and Drug Administration
Published: 1990-01-26

Substantially Equivalent

American Orthodontics

FDA 510(k) clearance K896249 for BANDTITE GLASS IONOMER CEMENT, Substantially Equivalent on 1990-01-26. Applicant: American Orthodontics. Device class: 2.

Clearance details

Applicant: American Orthodontics
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1989-10-30
Decision date: 1990-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheboygan, WI, 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.