Cleared Traditional

CONICAST, INTRACAST, OMECAST

K912567 · Metalor Dental USA Corp. · Dental
Jul 1991
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K912567 is an FDA 510(k) clearance for the CONICAST, INTRACAST, OMECAST, a Attachment, Precision, All (Class I — General Controls, product code EGG), submitted by Metalor Dental USA Corp. (Rockville Centre, US). The FDA issued a Cleared decision on July 2, 1991, 21 days after receiving the submission on June 11, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.3165.

Submission Details

510(k) Number K912567 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 1991
Decision Date July 02, 1991
Days to Decision 21 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EGG — Attachment, Precision, All
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3165

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