Cleared Special

K210694 - Silent Nite Sleep Appliance with the Glidewell Hinge

K210694 is an FDA 510(k) clearance for Silent Nite Sleep Appliance with the Gl..., manufactured by Prismatik Dentalcraft, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Special 510(k) pathway after a 100-day FDA review.

K210694 · Prismatik Dentalcraft, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2021
Decision
100d
Days
Class 2
Risk

K210694 is an FDA 510(k) clearance for the Silent Nite Sleep Appliance with the Glidewell Hinge. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on June 16, 2021 after a review of 100 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K210694

510(k) Number K210694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2021
Decision Date June 16, 2021
Days to Decision 100 days
Submission Type Special
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
28d faster than avg
Panel avg: 128d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Qserve Group, Us, Inc.
Patsy J Trisler

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 216
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K210694.
SmartGuard Anti-Snoring Device
K200657 · Smartguard Rx, Inc. · Aug 2021
mmRNA appliance
K210203 · Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) · Aug 2021
Snore Bandit
K210910 · Snorebandit, LLC · Jul 2021
Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
K203606 · Meris Investment Group · Mar 2021
Classic
K203477 · Orthoapnea S.L. · Feb 2021
Advanced Dental Appliance
K203462 · Dasoft Partners · Feb 2021
K210694 · Silent Nite Sleep Appliance with the Glidewell Hinge
Download PDF FDA Summary Prismatik Dentalcraft…