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FDA 510(k)

Bluephase PowerCure

K-Number: K190272 · 2019-07-03

Decision Date2019-07-03
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bluephase PowerCure is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2019-07-03 under 510(k) number K190272. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bluephase PowerCure?

Bluephase PowerCure is a medical device that received FDA 510(k) clearance on 2019-07-03. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K190272.

When did Bluephase PowerCure receive FDA 510(k) clearance?

Bluephase PowerCure received FDA 510(k) clearance on 2019-07-03, under 510(k) number K190272.

Who is the listed applicant for Bluephase PowerCure?

The FDA 510(k) record lists Ivoclar Vivadent, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bluephase PowerCure?

The FDA product code for Bluephase PowerCure is EBZ.

Related Clinical Trials

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.

Other records listing Ivoclar Vivadent, AG as applicant

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.

View all 18 devices →

Related Devices (Code: EBZ)

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.

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.