enCore Impression Material— 510(k) K251926

Name: FDA 510(k) clearance K251926
Creator: U.S. Food and Drug Administration
Published: 2026-03-17

Substantially Equivalent

Encore Guards

FDA 510(k) clearance K251926 for enCore Impression Material, Substantially Equivalent on 2026-03-17. Applicant: Encore Guards. Device class: 2.

Summary

Encore Guards' enCore Impression Material is filed under SHI, over-the-counter impression material for fabricating patient-matched mouthguards. The record doesn't describe the material beyond its name and that code name.

Class II, 21 CFR 872.3660. Dental is both the classification panel and the review panel. It was a Traditional 510(k).

Encore Guards filed from Santa Ana, California. The decision came 267 calendar days after receipt (June 23, 2025 to March 17, 2026).

Clearance details

Applicant: Encore Guards
Product code: Product code SHI
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2025-06-23
Decision date: 2026-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.