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 the device name listed in this FDA 510(k) record. The listed applicant is Dental Solutions, LLC. It received FDA 510(k) clearance on 2016-06-15 under 510(k) 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. The listed applicant is Dental Solutions, LLC. The 510(k) number is K160498.

When did Dentivera Milling Disc receive FDA 510(k) clearance?

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

Who is the listed applicant for Dentivera Milling Disc?

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

What is the FDA product code for Dentivera Milling Disc?

The FDA product code for Dentivera Milling Disc is EBI.

Related Devices (Code: EBI)

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.

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material Corporation

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.