Cleared Traditional

REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR

May 2007
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K070327 is an FDA 510(k) clearance for the REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR, a Device, Anti-snoring (Class II — Special Controls, product code LRK), submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on May 25, 2007, 109 days after receiving the submission on February 5, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number K070327 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2007
Decision Date May 25, 2007
Days to Decision 109 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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

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