Cleared Traditional

K130130 - ATG/SM-OSA APPLIANCES

K130130 is an FDA 510(k) clearance for ATG/SM-OSA APPLIANCES, manufactured by Selane Products, Inc.. The device is a Class 2 Dental device with product code LQZ cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K130130 · Selane Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
221d
Days
Class 2
Risk

K130130 is an FDA 510(k) clearance for the ATG/SM-OSA APPLIANCES. Classified as Device, Jaw Repositioning (product code LQZ), Class II - Special Controls.

Submitted by Selane Products, Inc. (Bradenton, US). The FDA issued a Cleared decision on August 26, 2013 after a review of 221 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Selane Products, Inc. devices

FDA 510(k) Submission Details - K130130

510(k) Number K130130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 127d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LQZ Device Classification - Class 2, Special Controls

Product Code LQZ Device, Jaw Repositioning
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.