Cleared Traditional

ATG/SM-OSA APPLIANCES

K130130 · Selane Products, Inc. · Dental

Aug 2013

Decision

221d

Days

Class 2

Risk

About This 510(k) Submission

K130130 is an FDA 510(k) clearance for the ATG/SM-OSA APPLIANCES, a Device, Jaw Repositioning (Class II — Special Controls, product code LQZ), submitted by Selane Products, Inc. (Bradenton, US). The FDA issued a Cleared decision on August 26, 2013, 221 days after receiving the submission on January 17, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number	K130130 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 2013
Decision Date	August 26, 2013
Days to Decision	221 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF