Cleared Traditional

AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM

K982088 · Ortho Kinetics Corp. · Dental
Sep 1998
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K982088 is an FDA 510(k) clearance for the AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM, 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 September 4, 1998, 81 days after receiving the submission on June 15, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.5500.

Submission Details

510(k) Number K982088 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 1998
Decision Date September 04, 1998
Days to Decision 81 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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