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FDA 510(k)

Premium Teeth Resin

K-Number: K240538 · 2024-07-19

ApplicantFormlabs Ohio, Inc.
Decision Date2024-07-19
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Premium Teeth Resin is the device name listed in this FDA 510(k) record. The listed applicant is Formlabs Ohio, Inc.. It received FDA 510(k) clearance on 2024-07-19 under 510(k) number K240538. 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 Premium Teeth Resin?

Premium Teeth Resin is a medical device that received FDA 510(k) clearance on 2024-07-19. The listed applicant is Formlabs Ohio, Inc.. The 510(k) number is K240538.

When did Premium Teeth Resin receive FDA 510(k) clearance?

Premium Teeth Resin received FDA 510(k) clearance on 2024-07-19, under 510(k) number K240538.

Who is the listed applicant for Premium Teeth Resin?

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

What is the FDA product code for Premium Teeth Resin?

The FDA product code for Premium Teeth Resin is EBG.

Other records listing Formlabs Ohio, Inc. as applicant

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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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

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

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