Cleared Traditional

K251926 - enCore Impression Material (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.