ORAL-B ULTRAFLOSS WITH FLLUORIDE— 510(k) K943157

Name: FDA 510(k) clearance K943157
Creator: U.S. Food and Drug Administration
Published: 1995-04-27

Substantially Equivalent

Oral-B Laboratories

FDA 510(k) clearance K943157 for ORAL-B ULTRAFLOSS WITH FLLUORIDE, Substantially Equivalent on 1995-04-27. Applicant: Oral-B Laboratories. Device class: 1.

Clearance details

Applicant: Oral-B Laboratories
Product code: Code JES
Device class: Class 1
Regulation: 21 CFR 872.6390
Advisory panel: Dental
Date received: 1994-07-01
Decision date: 1995-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, 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.