Cleared Traditional

DENTAL CONNECTOR PRECISION ATTACHMENT

K912435 · Metalor Dental USA Corp. · Dental
Aug 1991
Decision
86d
Days
Class 1
Risk

About This 510(k) Submission

K912435 is an FDA 510(k) clearance for the DENTAL CONNECTOR PRECISION ATTACHMENT, 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 August 28, 1991, 86 days after receiving the submission on June 3, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.3165.

Submission Details

510(k) Number K912435 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 1991
Decision Date August 28, 1991
Days to Decision 86 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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