Cleared Traditional

K203712 - The Slide

K203712 is an FDA 510(k) clearance for The Slide, manufactured by Biotex, Inc.. The device is a Class 2 Dental device with product code LQZ cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K203712 · Biotex, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
211d
Days
Class 2
Risk

K203712 is an FDA 510(k) clearance for the The Slide. Classified as Device, Jaw Repositioning (product code LQZ), Class II - Special Controls.

Submitted by Biotex, Inc. (Houston, US). The FDA issued a Cleared decision on July 20, 2021 after a review of 211 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 Biotex, Inc. devices

FDA 510(k) Submission Details - K203712

510(k) Number K203712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2020
Decision Date July 20, 2021
Days to Decision 211 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
83d slower than avg
Panel avg: 128d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LQZ Device Classification - Class 2, Special Controls

Product Code LQZ Device, Jaw Repositioning
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 - LQZ Device, Jaw Repositioning

All 17
Devices cleared under the same product code (LQZ) and FDA review panel - the closest regulatory comparables to K203712.
AIO Breathe
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RADx Intraoral Appliance for Snoring and Sleep Apnea
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Slow Wave DS8
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The NightBlocks Appliance
K192581 · Advanced Facialdontics, LLC · Jan 2020
SML-OSA2 Appliances
K162816 · Selane Products, Inc. · Jul 2017
ATG/SM-OSA APPLIANCES
K130130 · Selane Products, Inc. · Aug 2013