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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 a medical device manufactured by Grindguard, Inc.. It received FDA 510(k) clearance on 2026-02-25 under approval 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. It is manufactured by Grindguard, Inc.. The 510(k) number is K251724.

When was Remi Impression Material approved by the FDA?

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

What company makes Remi Impression Material?

Remi Impression Material is manufactured by Grindguard, Inc..

What is the FDA product code for Remi Impression Material?

The FDA product code for Remi Impression Material is SHI.

Other Devices by Grindguard, Inc.

Related Devices (Code: SHI)

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.