Cleared Traditional

POWER COINS GLOW IN THE DARK LIGATURES

K980864 · Ortho Kinetics Corp. · Dental
Apr 1998
Decision
46d
Days
Class 1
Risk

About This 510(k) Submission

K980864 is an FDA 510(k) clearance for the POWER COINS GLOW IN THE DARK LIGATURES, a Band, Elastic, Orthodontic (Class I — General Controls, product code ECI), submitted by Ortho Kinetics Corp. (Vista, US). The FDA issued a Cleared decision on April 20, 1998, 46 days after receiving the submission on March 5, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K980864 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1998
Decision Date April 20, 1998
Days to Decision 46 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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