Cleared Traditional

LC TRAY MATERIAL

K923979 · Dentsply Intl. · Dental
Nov 1992
Decision
103d
Days
Class 1
Risk

About This 510(k) Submission

K923979 is an FDA 510(k) clearance for the LC TRAY MATERIAL, a Material, Impression Tray, Resin (Class I — General Controls, product code EBH), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on November 17, 1992, 103 days after receiving the submission on August 6, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.3670.

Submission Details

510(k) Number K923979 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 1992
Decision Date November 17, 1992
Days to Decision 103 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBH — Material, Impression Tray, Resin
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3670