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FDA 510(k)

VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS

K-Number: K102640 · 2011-03-25

ApplicantVertex-Dental B.V.
Decision Date2011-03-25
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS 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 2011-03-25 under 510(k) number K102640. 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 SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS?

VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS is a medical device that received FDA 510(k) clearance on 2011-03-25. The listed applicant is Vertex-Dental B.V.. The 510(k) number is K102640.

When did VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS receive FDA 510(k) clearance?

VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS received FDA 510(k) clearance on 2011-03-25, under 510(k) number K102640.

Who is the listed applicant for VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS?

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 SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS?

The FDA product code for VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS 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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