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FDA 510(k)

Tetric plus Fill;Tetric plus Flow

K-Number: K261485 · 2026-07-01

ApplicantIvoclar Vivadent, Inc.
Decision Date2026-07-01
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Tetric plus Fill;Tetric plus Flow is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2026-07-01 under 510(k) number K261485. 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 plus Fill;Tetric plus Flow?

Tetric plus Fill;Tetric plus Flow is a medical device that received FDA 510(k) clearance on 2026-07-01. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K261485.

When did Tetric plus Fill;Tetric plus Flow receive FDA 510(k) clearance?

Tetric plus Fill;Tetric plus Flow received FDA 510(k) clearance on 2026-07-01, under 510(k) number K261485.

Who is the listed applicant for Tetric plus Fill;Tetric plus Flow?

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

What is the FDA product code for Tetric plus Fill;Tetric plus Flow?

The FDA product code for Tetric plus Fill;Tetric plus Flow is EBF.

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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.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.K261357Grandio disc multicolorVoco GmbH

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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