Cleared Traditional

CLASS III REVERSE PULL FACEMASK

K980436 · Ortho Kinetics Corp. · Dental
Apr 1998
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K980436 is an FDA 510(k) clearance for the CLASS III REVERSE PULL FACEMASK, a Headgear, Extraoral, Orthodontic (Class II — Special Controls, product code DZB), submitted by Ortho Kinetics Corp. (Vista, US). The FDA issued a Cleared decision on April 27, 1998, 82 days after receiving the submission on February 4, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.5500.

Submission Details

510(k) Number K980436 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 1998
Decision Date April 27, 1998
Days to Decision 82 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code DZB — Headgear, Extraoral, Orthodontic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5500

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