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FDA 510(k)

dima Print Teeth & Temp

K-Number: K233868 · 2024-05-23

ApplicantKulzer, LLC
Decision Date2024-05-23
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

dima Print Teeth & Temp is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, LLC. It received FDA 510(k) clearance on 2024-05-23 under 510(k) number K233868. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the dima Print Teeth & Temp?

dima Print Teeth & Temp is a medical device that received FDA 510(k) clearance on 2024-05-23. The listed applicant is Kulzer, LLC. The 510(k) number is K233868.

When did dima Print Teeth & Temp receive FDA 510(k) clearance?

dima Print Teeth & Temp received FDA 510(k) clearance on 2024-05-23, under 510(k) number K233868.

Who is the listed applicant for dima Print Teeth & Temp?

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

What is the FDA product code for dima Print Teeth & Temp?

The FDA product code for dima Print Teeth & Temp is EBG.

Other records listing Kulzer, LLC as applicant

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Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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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