FDA 510(k)

Ecosite Bulk Fill

K-Number: K171772 · 2018-01-31

Decision Date2018-01-31

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Ecosite Bulk Fill is the device name listed in this FDA 510(k) record. The listed applicant is Dmg USA, Inc.. It received FDA 510(k) clearance on 2018-01-31 under 510(k) number K171772. 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 Ecosite Bulk Fill?

Ecosite Bulk Fill is a medical device that received FDA 510(k) clearance on 2018-01-31. The listed applicant is Dmg USA, Inc.. The 510(k) number is K171772.

When did Ecosite Bulk Fill receive FDA 510(k) clearance?

Ecosite Bulk Fill received FDA 510(k) clearance on 2018-01-31, under 510(k) number K171772.

Who is the listed applicant for Ecosite Bulk Fill?

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

What is the FDA product code for Ecosite Bulk Fill?

The FDA product code for Ecosite Bulk Fill is EBF.

Other records listing Dmg USA, Inc. 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.

K160443TempoCem Clear

Related Devices (Code: EBF)

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group International K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group International K260805Dual CoreVericom Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.