Cleared Traditional

RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE

K942689 · Ranir/Dcp Corp. · Dental
Apr 1995
Decision
324d
Days
Class 1
Risk

About This 510(k) Submission

K942689 is an FDA 510(k) clearance for the RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE, a Floss, Dental (Class I — General Controls, product code JES), submitted by Ranir/Dcp Corp. (Grand Rapids, US). The FDA issued a Cleared decision on April 27, 1995, 324 days after receiving the submission on June 7, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.6390.

Submission Details

510(k) Number K942689 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 1994
Decision Date April 27, 1995
Days to Decision 324 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code JES — Floss, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6390

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