Cleared Abbreviated

K170578 - True Function Adjustable Herbst Appliances

K170578 is an FDA 510(k) clearance for True Function Adjustable Herbst Appliances, manufactured by True Function Laboratory, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 270-day FDA review.

K170578 · True Function Laboratory, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
270d
Days
Class 2
Risk

K170578 is an FDA 510(k) clearance for the True Function Adjustable Herbst Appliances. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by True Function Laboratory, Inc. (La Mesa, US). The FDA issued a Cleared decision on November 24, 2017 after a review of 270 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all True Function Laboratory, Inc. devices

FDA 510(k) Submission Details - K170578

510(k) Number K170578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2017
Decision Date November 24, 2017
Days to Decision 270 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 127d · This submission: 270d
Pathway characteristics
Standards-based clearance path.

LRK Device Classification - Class 2, Special Controls

Product Code LRK Device, Anti-snoring
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.

Regulatory Consultant

Azar & Associates
Nicolas Azar

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LRK Device, Anti-snoring

All 167
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K170578.
The Panthera Anti-Snoring X3 Device
K171576 · Panthera Dental, Inc. · Feb 2018
Snorer's Friend
K171529 · Scope Healthcare Technologies Pty, Ltd. · Jan 2018
Meridian PM
K170053 · The Center For Craniofacial & Dental Sleep Medicine · Nov 2017
SnoreRx
K170825 · Apnea Sciences Corporation · Aug 2017
O2Vent W
K171316 · Oventus Manufacturing Pty, Ltd. · Jul 2017
ASD Oral Appliances
K163580 · American Sleep Dentistry · Jun 2017