Skip to content

Damon 3 Modified

by Ormco Corporation

510(k) K052477

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052477 Date30 Nov 2005ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0203-06 FDA Unclassified (pre-2012) initiated 3 Nov 2005
    • Terminated Z-0204-06 FDA Unclassified (pre-2012) initiated 3 Nov 2005

    Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DYW
FDA applicant
Ormco Corp.
Device class
Class II
Regulation
21 CFR Part 872.5470
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Damon 3 Modified is a plastic orthodontic bracket device. It is classified as a Class 2 medical device under the Dental specialty.

It was cleared by the FDA through the traditional 510(k) pathway (K052477) on November 30, 2005, and is substantially equivalent to a predicate device. The device is manufactured by Ormco Corporation and assigned product code DYW under regulation number 872.5470.

Other devices from Ormco Corporation

See all devices from Ormco Corporation →

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Damon 3 Modified used for?

    The Damon 3 Modified is a plastic orthodontic bracket designed for use in dental applications to hold archwires in place during orthodontic treatment, facilitating tooth movement as part of a fixed appliance system.

  • Who manufactures the Damon 3 Modified and where is it made?

    The Damon 3 Modified is manufactured by Ormco Corporation, with manufacturing operations based in Orange, California, United States, as indicated by the facility address and registration details in the FDA database.

  • How was the Damon 3 Modified cleared for market release?

    The Damon 3 Modified received FDA clearance through the traditional 510(k) pathway under submission K052477, determined to be substantially equivalent to a predicate device, and was cleared on November 30, 2005.