Cleared Traditional

C.A.R.E. Appliance (DNA, mRNA, mmRNA) (K230947) - FDA 510(k) Clearance

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

K230947 · Vivos Therapeutics, Inc. · Dental device
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Nov 2023
Decision
238d
Days
Class 2
Risk

K230947 is an FDA 510(k) clearance for the C.A.R.E. Appliance (DNA, mRNA, mmRNA). Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Vivos Therapeutics, Inc. (Murray, US). The FDA issued a Cleared decision on November 28, 2023 after a review of 238 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 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 Vivos Therapeutics, Inc. devices

Submission Details

510(k) Number K230947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2023
Decision Date November 28, 2023
Days to Decision 238 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
111d slower than avg
Panel avg: 127d · This submission: 238d
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.

Regulatory Consultant

Eyedeas Company
Colette Cozean

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 79
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K230947.
Difiney Anti Snoring Device
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airVata™
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Aniti-Snore Mouthguard+
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Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)
K233434 · Prismatik Dentalcraft, Inc. · Nov 2023
The AVEOtsd (Tongue Stabilizing Device) Mouthpiece
K231663 · Innovative Health Technologies (Nz), Ltd. · Sep 2023
ApneaRX Pro
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