FDA 510(k)

Remi Impression Material

K-Number: K251724 · 2026-02-25

Decision Date2026-02-25

Product CodeSHI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Remi Impression Material is the device name listed in this FDA 510(k) record. The listed applicant is Grindguard, Inc.. It received FDA 510(k) clearance on 2026-02-25 under 510(k) number K251724. 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 Remi Impression Material?

Remi Impression Material is a medical device that received FDA 510(k) clearance on 2026-02-25. The listed applicant is Grindguard, Inc.. The 510(k) number is K251724.

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

Remi Impression Material received FDA 510(k) clearance on 2026-02-25, under 510(k) number K251724.

Who is the listed applicant for Remi Impression Material?

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

What is the FDA product code for Remi Impression Material?

The FDA product code for Remi Impression Material is SHI.

Other records listing Grindguard, Inc. 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.

K243516Remi Custom Night Guard

Related Devices (Code: SHI)

K251926enCore Impression MaterialEncore Guards

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.