Cleared Traditional

DENT-O-CRYL ORTHODONTIC ACRYLIC

K942667 · Dentauraum, Inc. · Dental
Feb 1995
Decision
252d
Days
Class 1
Risk

About This 510(k) Submission

K942667 is an FDA 510(k) clearance for the DENT-O-CRYL ORTHODONTIC ACRYLIC, a Positioner, Tooth, Preformed (Class I — General Controls, product code KMY), submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on February 13, 1995, 252 days after receiving the submission on June 6, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.5525.

Submission Details

510(k) Number K942667 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 1994
Decision Date February 13, 1995
Days to Decision 252 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KMY — Positioner, Tooth, Preformed
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.5525

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