Cleared Traditional

INTERDENTAL WEDGES

K840984 · Healthco, Inc. · Dental
Apr 1984
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K840984 is an FDA 510(k) clearance for the INTERDENTAL WEDGES, a Instruments, Dental Hand (Class I — General Controls, product code DZN), submitted by Healthco, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 13, 1984, 38 days after receiving the submission on March 6, 1984. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K840984 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 1984
Decision Date April 13, 1984
Days to Decision 38 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code DZN — Instruments, Dental Hand
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565