Cleared Traditional

K262421 - Daybreak Impression Material

K262421 is an FDA 510(k) clearance for Daybreak Impression Material, manufactured by Sleepcare, LLC. The device is a Class 2 Dental device with product code SHI cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K262421 · Sleepcare, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
96d
Days
Class 2
Risk

K262421 is an FDA 510(k) clearance for the Daybreak Impression Material. Classified as Impression Material For Fabrication Of Patient-matched Mouthguards, Over-the-counter (product code SHI), Class II - Special Controls.

Submitted by Sleepcare, LLC (Los Angeles, US). The FDA issued a Cleared decision on October 20, 2026 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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.

FDA 510(k) Submission Details - K262421

510(k) Number K262421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2026
Decision Date October 20, 2026
Days to Decision 96 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
32d faster than avg
Panel avg: 128d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SHI Device Classification - Class 2, Special Controls

Product Code SHI Impression Material For Fabrication Of Patient-matched Mouthguards, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
Definition An Over-the-counter Device That Is Intended To Reproduce The Structure Of A Patient's Teeth And Gums For The Fabrication Of Patient-matched Mouthguards/nightguards.
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.

K262421 · Daybreak Impression Material
Download PDF FDA Summary Sleepcare, LLC