Cleared Traditional

ORTHODONTIC BITE

K922984 · American Orthodontics · Dental
Mar 1993
Decision
282d
Days
Class 2
Risk

About This 510(k) Submission

K922984 is an FDA 510(k) clearance for the ORTHODONTIC BITE, a Device, Anti-snoring (Class II — Special Controls, product code LRK), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on March 31, 1993, 282 days after receiving the submission on June 22, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number K922984 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 1992
Decision Date March 31, 1993
Days to Decision 282 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code LRK — Device, Anti-snoring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5570

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