Cleared Traditional

K251926 - enCore Impression Material

K251926 is an FDA 510(k) clearance for enCore Impression Material, manufactured by Encore Guards. The device is a Class 2 Dental device with product code SHI cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K251926 · Encore Guards · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
267d
Days
Class 2
Risk

K251926 is an FDA 510(k) clearance for the enCore Impression Material. Classified as Impression Material For Fabrication Of Patient-matched Mouthguards, Over-the-counter (product code SHI), Class II - Special Controls.

Submitted by Encore Guards (Santa Ana, US). The FDA issued a Cleared decision on March 17, 2026 after a review of 267 days - an extended review cycle.

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 Encore Guards devices

FDA 510(k) Submission Details - K251926

510(k) Number K251926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2025
Decision Date March 17, 2026
Days to Decision 267 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
140d slower than avg
Panel avg: 127d · This submission: 267d
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.