Cleared Abbreviated

Advanced Dental Applicance (K172991) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K172991 · Dasoft Partners · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
286d
Days
Class 2
Risk

K172991 is an FDA 510(k) clearance for the Advanced Dental Applicance. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Dasoft Partners (San Diego, US). The FDA issued a Cleared decision on July 10, 2018 after a review of 286 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 Dasoft Partners devices

Submission Details

510(k) Number K172991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2017
Decision Date July 10, 2018
Days to Decision 286 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
159d slower than avg
Panel avg: 127d · This submission: 286d
Pathway characteristics
Standards-based clearance path.

Device Classification

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

Aschwartz Consulting
Alyssa Schwartz

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 80
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K172991.
ApnoDent Appliance
K181123 · Apnomed, Inc. · Nov 2018
Oral Device OA, Oral Device S
K181396 · Passion For Life Healthcare (Uk) Limited · Nov 2018
myTAP2
K181482 · Airway Management, Inc. · Aug 2018
Express 4 Sleep appliance/CPAP Sidekick appliance
K173856 · Moses Appliances, LLC · Jun 2018
ZQuiet
K180124 · Sleeping Well, LLC · Jun 2018
REST EAZY Appliance
K172760 · Insert Molding Solutions, Inc. · Mar 2018