Cleared Traditional

ALASTIK NS

K923999 · Unitek Corp. · Dental
Jun 1993
Decision
318d
Days
Class 1
Risk

About This 510(k) Submission

K923999 is an FDA 510(k) clearance for the ALASTIK NS, a Band, Elastic, Orthodontic (Class I — General Controls, product code ECI), submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on June 24, 1993, 318 days after receiving the submission on August 10, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K923999 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 1992
Decision Date June 24, 1993
Days to Decision 318 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code ECI — Band, Elastic, Orthodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.5410

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