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FDA 510(k)

ClearClub Impression Material

K-Number: K261888 · 2026-09-16

ApplicantClearClub
Decision Date2026-09-16
Product CodeSHI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ClearClub Impression Material is the device name listed in this FDA 510(k) record. The listed applicant is ClearClub. It received FDA 510(k) clearance on 2026-09-16 under 510(k) number K261888. 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 ClearClub Impression Material?

ClearClub Impression Material is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is ClearClub. The 510(k) number is K261888.

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

ClearClub Impression Material received FDA 510(k) clearance on 2026-09-16, under 510(k) number K261888.

Who is the listed applicant for ClearClub Impression Material?

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

What is the FDA product code for ClearClub Impression Material?

The FDA product code for ClearClub Impression Material is SHI.

Related Devices (Code: SHI)

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.

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Official Source

View on FDA Database →

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

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