Cleared Traditional

JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED

K935440 · Johnson & Johnson Consumer Products, Inc. · Dental
Feb 1994
Decision
83d
Days
Class 1
Risk

About This 510(k) Submission

K935440 is an FDA 510(k) clearance for the JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED, a Floss, Dental (Class I — General Controls, product code JES), submitted by Johnson & Johnson Consumer Products, Inc. (Skillman, US). The FDA issued a Cleared decision on February 3, 1994, 83 days after receiving the submission on November 12, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.6390.

Submission Details

510(k) Number K935440 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1993
Decision Date February 03, 1994
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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

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