Cleared Traditional

K261888 - ClearClub Impression Material

K261888 is an FDA 510(k) clearance for ClearClub Impression Material, manufactured by ClearClub. The device is a Class 2 Dental device with product code SHI cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K261888 · ClearClub · Dental device
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Sep 2026
Decision
103d
Days
Class 2
Risk

K261888 is an FDA 510(k) clearance for the ClearClub Impression Material. Classified as Impression Material For Fabrication Of Patient-matched Mouthguards, Over-the-counter (product code SHI), Class II - Special Controls.

Submitted by ClearClub (Inglewood, US). The FDA issued a Cleared decision on September 16, 2026 after a review of 103 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.

View all ClearClub devices

FDA 510(k) Submission Details - K261888

510(k) Number K261888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2026
Decision Date September 16, 2026
Days to Decision 103 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
25d faster than avg
Panel avg: 128d · This submission: 103d
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.