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FDA 510(k)

BRACE EZE

K-Number: K020009 · 2002-02-11

ApplicantUdent, Inc.
Decision Date2002-02-11
Product CodeEGD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRACE EZE is the device name listed in this FDA 510(k) record. The listed applicant is Udent, Inc.. It received FDA 510(k) clearance on 2002-02-11 under 510(k) number K020009. The device is classified under product code EGD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRACE EZE?

BRACE EZE is a medical device that received FDA 510(k) clearance on 2002-02-11. The listed applicant is Udent, Inc.. The 510(k) number is K020009.

When did BRACE EZE receive FDA 510(k) clearance?

BRACE EZE received FDA 510(k) clearance on 2002-02-11, under 510(k) number K020009.

Who is the listed applicant for BRACE EZE?

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

What is the FDA product code for BRACE EZE?

The FDA product code for BRACE EZE is EGD.

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Related Devices (Code: EGD)

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.

K945535GLENROE ORTHO-SILGlenroe TechnologiesK924024ORTHO WAXHeraeus Kulzer, Inc.K923586BURNOUT MATERIALDentsply Intl.K914892SALIVA-STIMOrion Diagnostica, Inc.K922380BITE RIM WAXDentsply Intl.K914513PALAVIT GHeraeus Kulzer, Inc.

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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