Cleared Traditional

SML-OSA2 Appliances

K162816 · Selane Products, Inc. · Dental
Jul 2017
Decision
294d
Days
Class 2
Risk

About This 510(k) Submission

K162816 is an FDA 510(k) clearance for the SML-OSA2 Appliances, a Device, Jaw Repositioning (Class II — Special Controls, product code LQZ), submitted by Selane Products, Inc. (Chatsworth, US). The FDA issued a Cleared decision on July 27, 2017, 294 days after receiving the submission on October 6, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number K162816 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 2016
Decision Date July 27, 2017
Days to Decision 294 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LQZ — Device, Jaw Repositioning
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5570