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FDA 510(k)

BRIGHT GOLD XH

K-Number: K041433 · 2004-08-19

ApplicantIvoclar Vivadent, Inc.
Decision Date2004-08-19
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRIGHT GOLD XH 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 2004-08-19 under 510(k) number K041433. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRIGHT GOLD XH?

BRIGHT GOLD XH is a medical device that received FDA 510(k) clearance on 2004-08-19. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K041433.

When did BRIGHT GOLD XH receive FDA 510(k) clearance?

BRIGHT GOLD XH received FDA 510(k) clearance on 2004-08-19, under 510(k) number K041433.

Who is the listed applicant for BRIGHT GOLD XH?

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 BRIGHT GOLD XH?

The FDA product code for BRIGHT GOLD XH is EJS.

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Related Devices (Code: EJS)

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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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