FDA 510(k)

Emerald Herbst

K-Number: K223624 · 2023-05-10

ApplicantIsland Dental Lab, Inc Dba Emerald Dental

Decision Date2023-05-10

Product CodeLRK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Emerald Herbst is the device name listed in this FDA 510(k) record. The listed applicant is Island Dental Lab, Inc Dba Emerald Dental. It received FDA 510(k) clearance on 2023-05-10 under 510(k) number K223624. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Emerald Herbst?

Emerald Herbst is a medical device that received FDA 510(k) clearance on 2023-05-10. The listed applicant is Island Dental Lab, Inc Dba Emerald Dental. The 510(k) number is K223624.

When did Emerald Herbst receive FDA 510(k) clearance?

Emerald Herbst received FDA 510(k) clearance on 2023-05-10, under 510(k) number K223624.

Who is the listed applicant for Emerald Herbst?

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

What is the FDA product code for Emerald Herbst?

The FDA product code for Emerald Herbst is LRK.

Related Devices (Code: LRK)

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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.