Cleared Traditional

ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE (K971794) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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.