FDA 510(k)

enCore Impression Material

K-Number: K251926 · 2026-03-17

Decision Date2026-03-17

Product CodeSHI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

enCore Impression Material is the device name listed in this FDA 510(k) record. The listed applicant is Encore Guards. It received FDA 510(k) clearance on 2026-03-17 under 510(k) number K251926. The device is classified under product code SHI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the enCore Impression Material?

enCore Impression Material is a medical device that received FDA 510(k) clearance on 2026-03-17. The listed applicant is Encore Guards. The 510(k) number is K251926.

When did enCore Impression Material receive FDA 510(k) clearance?

enCore Impression Material received FDA 510(k) clearance on 2026-03-17, under 510(k) number K251926.

Who is the listed applicant for enCore Impression Material?

The FDA 510(k) record lists Encore Guards as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for enCore Impression Material?

The FDA product code for enCore Impression Material is SHI.

Other records listing Encore Guards as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252004enCore Night Guard

Related Devices (Code: SHI)

K251724Remi Impression MaterialGrindguard, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.