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FDA 510(k)

AMELOGEN PLUS

K-Number: K043119 · 2004-12-17

ApplicantUltradent Products, Inc.
Decision Date2004-12-17
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMELOGEN PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2004-12-17 under 510(k) number K043119. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMELOGEN PLUS?

AMELOGEN PLUS is a medical device that received FDA 510(k) clearance on 2004-12-17. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K043119.

When did AMELOGEN PLUS receive FDA 510(k) clearance?

AMELOGEN PLUS received FDA 510(k) clearance on 2004-12-17, under 510(k) number K043119.

Who is the listed applicant for AMELOGEN PLUS?

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

What is the FDA product code for AMELOGEN PLUS?

The FDA product code for AMELOGEN PLUS is EBF.

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Other records listing Ultradent Products, Inc. as applicant

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Related Devices (Code: EBF)

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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