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FDA 510(k)

VERTEX RAPID SIMPLIFIED

K-Number: K102654 · 2010-12-03

ApplicantVertex-Dental B.V.
Decision Date2010-12-03
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VERTEX RAPID SIMPLIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Vertex-Dental B.V.. It received FDA 510(k) clearance on 2010-12-03 under 510(k) number K102654. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTEX RAPID SIMPLIFIED?

VERTEX RAPID SIMPLIFIED is a medical device that received FDA 510(k) clearance on 2010-12-03. The listed applicant is Vertex-Dental B.V.. The 510(k) number is K102654.

When did VERTEX RAPID SIMPLIFIED receive FDA 510(k) clearance?

VERTEX RAPID SIMPLIFIED received FDA 510(k) clearance on 2010-12-03, under 510(k) number K102654.

Who is the listed applicant for VERTEX RAPID SIMPLIFIED?

The FDA 510(k) record lists Vertex-Dental B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERTEX RAPID SIMPLIFIED?

The FDA product code for VERTEX RAPID SIMPLIFIED is EBI.

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Other records listing Vertex-Dental B.V. 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.

K241071NextDent Jet Denture Base; NextDent Jet Denture TeethK231388NextDent BaseK221022NextDent Ortho FlexK191497NextDent Denture 3D+K162572NextDent Denture, E-DentureK123220VERTEX THERMOSENS RIGID

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Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.

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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