Cleared Traditional

CERAPALL 6 -- MODIFIED

K924292 · Metalor Dental USA Corp. · Dental
Mar 1993
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K924292 is an FDA 510(k) clearance for the CERAPALL 6 -- MODIFIED, a Alloy, Other Noble Metal (Class II — Special Controls, product code EJS), submitted by Metalor Dental USA Corp. (Rockville Centre, US). The FDA issued a Cleared decision on March 1, 1993, 245 days after receiving the submission on June 29, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K924292 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 1992
Decision Date March 01, 1993
Days to Decision 245 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJS — Alloy, Other Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060