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FDA 510(k)

VERTEX THERMOSENS RIGID

K-Number: K123220 · 2013-03-01

ApplicantVertex-Dental B.V.
Decision Date2013-03-01
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VERTEX THERMOSENS RIGID 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 2013-03-01 under 510(k) number K123220. 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 THERMOSENS RIGID?

VERTEX THERMOSENS RIGID is a medical device that received FDA 510(k) clearance on 2013-03-01. The listed applicant is Vertex-Dental B.V.. The 510(k) number is K123220.

When did VERTEX THERMOSENS RIGID receive FDA 510(k) clearance?

VERTEX THERMOSENS RIGID received FDA 510(k) clearance on 2013-03-01, under 510(k) number K123220.

Who is the listed applicant for VERTEX THERMOSENS RIGID?

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 THERMOSENS RIGID?

The FDA product code for VERTEX THERMOSENS RIGID 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-DentureK102640VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS

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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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