Cleared Traditional

INLAY WAX REGULAR

K854529 · The Hygenic Corp. · Dental
Mar 1986
Decision
117d
Days
Class 1
Risk

About This 510(k) Submission

K854529 is an FDA 510(k) clearance for the INLAY WAX REGULAR, 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 10, 1986, 117 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 K854529 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1985
Decision Date March 10, 1986
Days to Decision 117 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