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enCore Impression Material

by Encore Guards

510(k) K251926

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK251926 Date17 Mar 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
SHI
Device Class
Class II
Regulation
21 CFR Part 872.3660
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The enCore Impression Material is a dental impression material classified as an Impression Material for Fabrication of Patient-Matched Mouthguards, designed for creating precise oral impressions. It is intended for use in dental applications, specifically for capturing accurate molds of a patient’s teeth and surrounding structures to fabricate custom-fitted mouthguards or night guards.

This material is supplied as an over-the-counter product and is intended for single-use in dental settings. It is regulated under FDA 510(k) clearance (K251926) as a Class II device under regulation number 872.3660, with a product code of SHI. The material is not described as sterile or reusable, and no MRI safety information is provided in the specifications.

Other devices from Encore Guards

Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the enCore Impression Material specifically used for in dental applications?

    The enCore Impression Material is designed to create precise oral impressions for fabricating custom-fitted mouthguards or night guards. It captures detailed molds of a patient’s teeth and surrounding structures to ensure an accurate fit for protective dental devices.

  • Is the enCore Impression Material intended for single-use or repeated use in a dental setting?

    The enCore Impression Material is explicitly intended for single-use in dental settings, as stated in its description. This means each application is meant to be discarded after use to maintain hygiene and accuracy.

  • How is the enCore Impression Material supplied, and is it sterile?

    The enCore Impression Material is supplied as an over-the-counter product and is not described as sterile. Since it is intended for single-use in dental settings, proper sterilization of tools or surfaces used with it would be the responsibility of the clinician.

  • What regulatory pathway was followed for FDA clearance of the enCore Impression Material?

    The enCore Impression Material received FDA clearance through a Traditional 510(k) review (K251926) under the Dental Devices advisory committee (DE). It was classified as Substantially Equivalent (SESE) to a predicate device and falls under regulation number 872.3660, with a product code of SHI.