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FDA 510(k)

ENDOREZ

K-Number: K992097 · 1999-10-26

ApplicantUltradent Products, Inc.
Decision Date1999-10-26
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDOREZ 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 1999-10-26 under 510(k) number K992097. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOREZ?

ENDOREZ is a medical device that received FDA 510(k) clearance on 1999-10-26. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K992097.

When did ENDOREZ receive FDA 510(k) clearance?

ENDOREZ received FDA 510(k) clearance on 1999-10-26, under 510(k) number K992097.

Who is the listed applicant for ENDOREZ?

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 ENDOREZ?

The FDA product code for ENDOREZ is KIF.

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Other records listing Ultradent Products, Inc. as applicant

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Related Devices (Code: KIF)

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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