FDA 510(k)

Archy Dental Imaging

K-Number: K251880 · 2025-11-21

Decision Date2025-11-21

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Archy Dental Imaging is the device name listed in this FDA 510(k) record. The listed applicant is Archy Dental, Inc.. It received FDA 510(k) clearance on 2025-11-21 under 510(k) number K251880. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Archy Dental Imaging?

Archy Dental Imaging is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is Archy Dental, Inc.. The 510(k) number is K251880.

When did Archy Dental Imaging receive FDA 510(k) clearance?

Archy Dental Imaging received FDA 510(k) clearance on 2025-11-21, under 510(k) number K251880.

Who is the listed applicant for Archy Dental Imaging?

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

What is the FDA product code for Archy Dental Imaging?

The FDA product code for Archy Dental Imaging is LLZ.

Related Devices (Code: LLZ)

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

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