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FDA 510(k)

RADIANCE PORCELAIN

K-Number: K042638 · 2004-12-17

ApplicantAurident, Inc.
Decision Date2004-12-17
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RADIANCE PORCELAIN is the device name listed in this FDA 510(k) record. The listed applicant is Aurident, Inc.. It received FDA 510(k) clearance on 2004-12-17 under 510(k) number K042638. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIANCE PORCELAIN?

RADIANCE PORCELAIN is a medical device that received FDA 510(k) clearance on 2004-12-17. The listed applicant is Aurident, Inc.. The 510(k) number is K042638.

When did RADIANCE PORCELAIN receive FDA 510(k) clearance?

RADIANCE PORCELAIN received FDA 510(k) clearance on 2004-12-17, under 510(k) number K042638.

Who is the listed applicant for RADIANCE PORCELAIN?

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

What is the FDA product code for RADIANCE PORCELAIN?

The FDA product code for RADIANCE PORCELAIN is EIH.

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Related Devices (Code: EIH)

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.

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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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