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FDA 510(k)

visio.lign color, visio.lign shield

K-Number: K240735 · 2024-12-12

ApplicantBredent GmbH & Co. KG
Decision Date2024-12-12
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

visio.lign color, visio.lign shield is the device name listed in this FDA 510(k) record. The listed applicant is Bredent GmbH & Co. KG. It received FDA 510(k) clearance on 2024-12-12 under 510(k) number K240735. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the visio.lign color, visio.lign shield?

visio.lign color, visio.lign shield is a medical device that received FDA 510(k) clearance on 2024-12-12. The listed applicant is Bredent GmbH & Co. KG. The 510(k) number is K240735.

When did visio.lign color, visio.lign shield receive FDA 510(k) clearance?

visio.lign color, visio.lign shield received FDA 510(k) clearance on 2024-12-12, under 510(k) number K240735.

Who is the listed applicant for visio.lign color, visio.lign shield?

The FDA 510(k) record lists Bredent GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for visio.lign color, visio.lign shield?

The FDA product code for visio.lign color, visio.lign shield is EBD.

Other records listing Bredent GmbH & Co. KG 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.

K152113BioHPP - breCAM.BioHPP

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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.

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