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FDA 510(k)

BLUEPHASE

K-Number: K033520 · 2003-12-05

ApplicantIvoclar Vivadent, Inc.
Decision Date2003-12-05
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BLUEPHASE is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2003-12-05 under 510(k) number K033520. 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?

BLUEPHASE is a medical device that received FDA 510(k) clearance on 2003-12-05. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K033520.

When did BLUEPHASE receive FDA 510(k) clearance?

BLUEPHASE received FDA 510(k) clearance on 2003-12-05, under 510(k) number K033520.

Who is the listed applicant for BLUEPHASE?

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

What is the FDA product code for BLUEPHASE?

The FDA product code for BLUEPHASE is EBZ.

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Related Devices (Code: EBZ)

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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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