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FDA 510(k)

Dentivera Milling Disc

K-Number: K160498 · 2016-06-15

Decision Date2016-06-15
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dentivera Milling Disc is a medical device manufactured by Dental Solutions, LLC. It received FDA 510(k) clearance on 2016-06-15 under approval number K160498. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dentivera Milling Disc?

Dentivera Milling Disc is a medical device that received FDA 510(k) clearance on 2016-06-15. It is manufactured by Dental Solutions, LLC. The 510(k) number is K160498.

When was Dentivera Milling Disc approved by the FDA?

Dentivera Milling Disc received FDA 510(k) clearance on 2016-06-15, under approval number K160498.

What company makes Dentivera Milling Disc?

Dentivera Milling Disc is manufactured by Dental Solutions, LLC.

What is the FDA product code for Dentivera Milling Disc?

The FDA product code for Dentivera Milling Disc is EBI.

Related Devices (Code: EBI)

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.