Cleared Traditional

K013808 - SLEEPBITE

K013808 is an FDA 510(k) clearance for SLEEPBITE, manufactured by Dental Imagineers, LLC. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K013808 · Dental Imagineers, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
76d
Days
Class 2
Risk

K013808 is an FDA 510(k) clearance for the SLEEPBITE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Dental Imagineers, LLC (Ocean, US). The FDA issued a Cleared decision on January 30, 2002 after a review of 76 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.

FDA 510(k) Submission Details - K013808

510(k) Number K013808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2001
Decision Date January 30, 2002
Days to Decision 76 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
52d faster than avg
Panel avg: 128d · This submission: 76d
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 214
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K013808.
SNORE-AID MAX
K022284 · Dental Imagineers, LLC · Dec 2002
NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER
K013687 · Steven K. Sue · May 2002
NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
K020893 · Dennis R. Bailey, Dds · May 2002
NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
K013049 · Dennis R. Bailey, Dds · Nov 2001
THE QUIET SLEEPER
K012142 · Precision Dental Laboratories, Inc. · Oct 2001
TONGUE STABILIZER DEVICE
K993381 · University of Otago · Dec 1999
K013808 · SLEEPBITE
Download PDF FDA Summary Dental Imagineers, LLC