FDA 510(k)

Tokuyama Rebase III

K-Number: K190940 · 2019-10-04

Decision Date2019-10-04

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Tokuyama Rebase III is the device name listed in this FDA 510(k) record. The listed applicant is Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2019-10-04 under 510(k) number K190940. 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 Tokuyama Rebase III?

Tokuyama Rebase III is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Tokuyama Dental Corporation. The 510(k) number is K190940.

When did Tokuyama Rebase III receive FDA 510(k) clearance?

Tokuyama Rebase III received FDA 510(k) clearance on 2019-10-04, under 510(k) number K190940.

Who is the listed applicant for Tokuyama Rebase III?

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

What is the FDA product code for Tokuyama Rebase III?

The FDA product code for Tokuyama Rebase III is EBI.

Other records listing Tokuyama Dental Corporation as applicant

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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.