Cleared Traditional

K973884 - ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE

K973884 is an FDA 510(k) clearance for ELASTIC MANDIBULAR ADVANCEMENT - TITRAT..., 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 87-day FDA review.

K973884 · Frantz Design, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
87d
Days
Class 2
Risk

K973884 is an FDA 510(k) clearance for the ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE. 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 January 9, 1998 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Frantz Design, Inc. devices

FDA 510(k) Submission Details - K973884

510(k) Number K973884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1997
Decision Date January 09, 1998
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
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 K973884.
SNORE-CURE ANTI-SNORING APPLIANCE
K980952 · Ortho-Tain, Inc. · Jun 1998
SNORE-EZZER
K974531 · Snore - Ezzer · Feb 1998
SNORING CONTROL DEVICE
K963591 · Kenneth Hilsen · Jan 1998
ADJUSTABLE THERASNORE
K973038 · Distar, Inc. · Nov 1997
ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE
K971794 · Frantz Design, Inc. · Sep 1997
SILENTNITE
K972424 · Glidewell Laboratories · Sep 1997