Cleared Traditional

K854530 - PREMIUM FLEXI-TOUGH
(FDA 510(k) Clearance)

K854530 · The Hygenic Corp. · Dental
Mar 1986
Decision
111d
Days
Class 1
Risk

K854530 is an FDA 510(k) clearance for the PREMIUM FLEXI-TOUGH, a Wax, Dental, Intraoral (Class I — General Controls, product code EGD), submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on March 4, 1986, 111 days after receiving the submission on November 13, 1985. This device falls under the Dental review panel. Regulated under 21 CFR 872.6890.

Submission Details

510(k) Number K854530 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1985
Decision Date March 04, 1986
Days to Decision 111 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EGD — Wax, Dental, Intraoral
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6890