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FDA 510(k)

Bifix Veneer LC, Bifix Veneer Try-In

K-Number: K252606 · 2026-03-20

ApplicantVoco GmbH
Decision Date2026-03-20
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bifix Veneer LC, Bifix Veneer Try-In is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K252606. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bifix Veneer LC, Bifix Veneer Try-In?

Bifix Veneer LC, Bifix Veneer Try-In is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is Voco GmbH. The 510(k) number is K252606.

When did Bifix Veneer LC, Bifix Veneer Try-In receive FDA 510(k) clearance?

Bifix Veneer LC, Bifix Veneer Try-In received FDA 510(k) clearance on 2026-03-20, under 510(k) number K252606.

Who is the listed applicant for Bifix Veneer LC, Bifix Veneer Try-In?

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

What is the FDA product code for Bifix Veneer LC, Bifix Veneer Try-In?

The FDA product code for Bifix Veneer LC, Bifix Veneer Try-In is EMA.

Other records listing Voco GmbH 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: EMA)

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.

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.