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FDA 510(k)

KATANA AVENCIA Block

K-Number: K153476 · 2016-08-23

ApplicantKuraray Noritake Dental, Inc.
Decision Date2016-08-23
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KATANA AVENCIA Block is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2016-08-23 under 510(k) number K153476. 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 KATANA AVENCIA Block?

KATANA AVENCIA Block is a medical device that received FDA 510(k) clearance on 2016-08-23. The listed applicant is Kuraray Noritake Dental, Inc.. The 510(k) number is K153476.

When did KATANA AVENCIA Block receive FDA 510(k) clearance?

KATANA AVENCIA Block received FDA 510(k) clearance on 2016-08-23, under 510(k) number K153476.

Who is the listed applicant for KATANA AVENCIA Block?

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

What is the FDA product code for KATANA AVENCIA Block?

The FDA product code for KATANA AVENCIA Block is EBF.

Other records listing Kuraray Noritake Dental, Inc. as applicant

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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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