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FDA 510(k)

Tetric CAD

K-Number: K173573 · 2018-06-07

ApplicantIvoclar Vivadent, AG
Decision Date2018-06-07
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Tetric CAD is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2018-06-07 under 510(k) number K173573. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tetric CAD?

Tetric CAD is a medical device that received FDA 510(k) clearance on 2018-06-07. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K173573.

When did Tetric CAD receive FDA 510(k) clearance?

Tetric CAD received FDA 510(k) clearance on 2018-06-07, under 510(k) number K173573.

Who is the listed applicant for Tetric CAD?

The FDA 510(k) record lists Ivoclar Vivadent, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tetric CAD?

The FDA product code for Tetric CAD is EBF.

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Other records listing Ivoclar Vivadent, AG 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.

K261485Tetric plus Fill;Tetric plus FlowK253953IPS e.max ZirconiaK252450Adhese 2K233995Ivotion Base PrintK210804Adhese Universal DC, Cention PrimerK211916IPS e.max One

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Related Devices (Code: EBF)

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.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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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