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FDA 510(k)

ORTHODONTIC COMPOSITE BRACKET SYSTEM

K-Number: K032625 · 2004-02-26

ApplicantUltradent Products, Inc.
Decision Date2004-02-26
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC COMPOSITE BRACKET SYSTEM 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 2004-02-26 under 510(k) number K032625. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHODONTIC COMPOSITE BRACKET SYSTEM?

ORTHODONTIC COMPOSITE BRACKET SYSTEM is a medical device that received FDA 510(k) clearance on 2004-02-26. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K032625.

When did ORTHODONTIC COMPOSITE BRACKET SYSTEM receive FDA 510(k) clearance?

ORTHODONTIC COMPOSITE BRACKET SYSTEM received FDA 510(k) clearance on 2004-02-26, under 510(k) number K032625.

Who is the listed applicant for ORTHODONTIC COMPOSITE BRACKET SYSTEM?

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 ORTHODONTIC COMPOSITE BRACKET SYSTEM?

The FDA product code for ORTHODONTIC COMPOSITE BRACKET SYSTEM is DYW.

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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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