Cleared Traditional

CERADELTA 2

K921794 · Metalor Dental USA Corp. · Dental
Jul 1992
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K921794 is an FDA 510(k) clearance for the CERADELTA 2, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Metalor Dental USA Corp. (Rockville Centre, US). The FDA issued a Cleared decision on July 2, 1992, 83 days after receiving the submission on April 10, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K921794 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 1992
Decision Date July 02, 1992
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJT — Alloy, Gold-based Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060

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