Cleared Traditional

K971794 - ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE

K971794 is an FDA 510(k) clearance for ELASTIC MANDIBULAR ADVANCEMENT (EMA) AP..., manufactured by Frantz Design, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K971794 · Frantz Design, Inc. · Dental device
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Sep 1997
Decision
137d
Days
Class 2
Risk

K971794 is an FDA 510(k) clearance for the ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Frantz Design, Inc. (Webster, US). The FDA issued a Cleared decision on September 29, 1997 after a review of 137 days - within the typical 510(k) review window.

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 Frantz Design, Inc. devices

FDA 510(k) Submission Details - K971794

510(k) Number K971794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1997
Decision Date September 29, 1997
Days to Decision 137 days
Submission Type Traditional
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
10d slower than avg
Panel avg: 127d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - LRK Device, Anti-snoring

All 112
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K971794.
SNORING CONTROL DEVICE
K963591 · Kenneth Hilsen · Jan 1998
ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE
K973884 · Frantz Design, Inc. · Jan 1998
ADJUSTABLE THERASNORE
K973038 · Distar, Inc. · Nov 1997
SILENTNITE
K972424 · Glidewell Laboratories · Sep 1997
SLEEP-IN BONE SCREW SYSTEM
K972023 · Influence, Inc. · Aug 1997
TOA
K972061 · W. Keith Thornton, D.D.S. · Aug 1997