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FDA 510(k)

Ecosite Bulk Fill

K-Number: K171772 · 2018-01-31

ApplicantDmg USA, Inc.
Decision Date2018-01-31
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ecosite Bulk Fill is a medical device manufactured by Dmg USA, Inc.. It received FDA 510(k) clearance on 2018-01-31 under approval 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. It is manufactured by Dmg USA, Inc.. The 510(k) number is K171772.

When was Ecosite Bulk Fill approved by the FDA?

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

What company makes Ecosite Bulk Fill?

Ecosite Bulk Fill is manufactured by Dmg USA, Inc..

What is the FDA product code for Ecosite Bulk Fill?

The FDA product code for Ecosite Bulk Fill is EBF.

Other Devices by Dmg USA, Inc.

K160443TempoCem Clear

Related Devices (Code: EBF)

K163207Filtek One Bulk Fill Restorative3M Company K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. K160049CharismaHeraeus Kulzer, LLC (Mitsui Chemicals Group) K162257P1145 Dental RestorativeKerr Corporation K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq FlowSchutz Dental GmbH K162107TPH Spectra+ Universal Composite RestorativeDentsply Sirona

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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