Cleared Traditional

METAL-LINED TRANSCEND CERAMIC BRACKET

K944286 · Unitek Corp. · Dental
Nov 1994
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K944286 is an FDA 510(k) clearance for the METAL-LINED TRANSCEND CERAMIC BRACKET, a Bracket, Plastic, Orthodontic (Class II — Special Controls, product code DYW), submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on November 29, 1994, 88 days after receiving the submission on September 2, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K944286 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 1994
Decision Date November 29, 1994
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code DYW — Bracket, Plastic, Orthodontic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5470

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