Cleared Traditional

K231663 - The AVEOtsd (Tongue Stabilizing Device)...

K231663 is an FDA 510(k) clearance for The AVEOtsd (Tongue Stabilizing Device)..., manufactured by Innovative Health Technologies (Nz), Ltd.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K231663 · Innovative Health Technologies (Nz), Ltd. · Dental device
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Sep 2023
Decision
103d
Days
Class 2
Risk

K231663 is an FDA 510(k) clearance for the The AVEOtsd (Tongue Stabilizing Device) Mouthpiece. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Innovative Health Technologies (Nz), Ltd. (Dunedin, NZ). The FDA issued a Cleared decision on September 18, 2023 after a review of 103 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 Innovative Health Technologies (Nz), Ltd. devices

FDA 510(k) Submission Details - K231663

510(k) Number K231663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2023
Decision Date September 18, 2023
Days to Decision 103 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 127d · This submission: 103d
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 85
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