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FDA 510(k)

Tetric PowerFill

K-Number: K183380 · 2019-03-14

ApplicantIvoclar Vivadent, AG
Decision Date2019-03-14
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Tetric PowerFill 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 2019-03-14 under 510(k) number K183380. 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 PowerFill?

Tetric PowerFill is a medical device that received FDA 510(k) clearance on 2019-03-14. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K183380.

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

Tetric PowerFill received FDA 510(k) clearance on 2019-03-14, under 510(k) number K183380.

Who is the listed applicant for Tetric PowerFill?

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 PowerFill?

The FDA product code for Tetric PowerFill is EBF.

Related Clinical Trials

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.

NCT06898411Clinical Evaluation on the Longevity of Glass Ceramic Based Single Tooth RestorationsCOMPLETEDNCT07622043Effectiveness of Two Different Desensitizing Dental VarnishesRECRUITING

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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