Cleared Traditional

RANIR HI-TECHNOLOGY DENTAL FLOSS

K955530 · Ranir/Dcp Corp. · Dental
Dec 1995
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K955530 is an FDA 510(k) clearance for the RANIR HI-TECHNOLOGY DENTAL FLOSS, a Toothbrush, Manual (Class I — General Controls, product code EFW), submitted by Ranir/Dcp Corp. (Grand Rapids, US). The FDA issued a Cleared decision on December 28, 1995, 24 days after receiving the submission on December 4, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.6855.

Submission Details

510(k) Number K955530 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 1995
Decision Date December 28, 1995
Days to Decision 24 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFW — Toothbrush, Manual
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6855

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