ORTHODONTIC COTTON ROLL HOLDERS— 510(k) K891354

Name: FDA 510(k) clearance K891354
Creator: U.S. Food and Drug Administration
Published: 1989-04-17

Substantially Equivalent

American Orthodontics

FDA 510(k) clearance K891354 for ORTHODONTIC COTTON ROLL HOLDERS, Substantially Equivalent on 1989-04-17. Applicant: American Orthodontics. Device class: 1.

Clearance details

Applicant: American Orthodontics
Product code: Code KHR
Device class: Class 1
Regulation: 21 CFR 872.6050
Advisory panel: Dental
Date received: 1989-03-10
Decision date: 1989-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheboygan, WI, US

Download summary PDF View on FDA.gov ↗

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K891054 — NON-STERILE GAUZE SPONGE1989-05-01
K890734 — DRY TIPS1989-03-10

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Data sourced from openFDA. This site is unofficial and independent of the FDA.