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FDA 510(k)

Filtek One Bulk Fill Restorative

K-Number: K163207 · 2016-11-28

Applicant3M Company
Decision Date2016-11-28
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Filtek One Bulk Fill Restorative is a medical device manufactured by 3M Company. It received FDA 510(k) clearance on 2016-11-28 under approval number K163207. 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 Filtek One Bulk Fill Restorative?

Filtek One Bulk Fill Restorative is a medical device that received FDA 510(k) clearance on 2016-11-28. It is manufactured by 3M Company. The 510(k) number is K163207.

When was Filtek One Bulk Fill Restorative approved by the FDA?

Filtek One Bulk Fill Restorative received FDA 510(k) clearance on 2016-11-28, under approval number K163207.

What company makes Filtek One Bulk Fill Restorative?

Filtek One Bulk Fill Restorative is manufactured by 3M Company.

What is the FDA product code for Filtek One Bulk Fill Restorative?

The FDA product code for Filtek One Bulk Fill Restorative is EBF.

Related Clinical Trials

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Related Devices (Code: EBF)

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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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