FDA Device Intelligence
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Bracket, Metal, Orthodontic

FDA product code EJF · Class 1 · Dental

37,417
Registered devices
148
Adverse events
8
Recalls
103
510(k) clearances

Devices with this code

Sprint® — Forestadent Bernhard Förster GmbHLEONE SPA — LEONE SPAEmpower Bracket — AMERICAN ORTHODONTICS CORPORATIONMasterSeries — AMERICAN ORTHODONTICS CORPORATIONStainless Steel Brackets — AMERICAN ORTHODONTICS CORPORATIONCarriere® SLX 3D™ — Ortho Organizers, Inc.Mini Master Series — AMERICAN ORTHODONTICS CORPORATIONMini Master Series — AMERICAN ORTHODONTICS CORPORATIONMini Master Series — AMERICAN ORTHODONTICS CORPORATIONSL PRO — Ortho Organizers, Inc.Iconix — AMERICAN ORTHODONTICS CORPORATIONStainless Steel Brackets — AMERICAN ORTHODONTICS CORPORATIONN.A. — DENTAURUM GmbH & Co.KGAXCESS — Gc Orthodontics America Inc.MICROARCH® — DENTSPLY SIRONA ORTHODONTICS INC.Empower Bracket — AMERICAN ORTHODONTICS CORPORATIONLP Low Profile — AMERICAN ORTHODONTICS CORPORATIONMini Master Series — AMERICAN ORTHODONTICS CORPORATIONMini Master Series — AMERICAN ORTHODONTICS CORPORATIONMini-Twin — ORMCO CORPORATIONMicro Twin Bracket — Ortho Arch Company IncLEONE SPA — LEONE SPALEONE SPA — LEONE SPALEONE SPA — LEONE SPA

Recent recalls

DateFirmReason
2020-01-14Ormco/SybronendoThe bracket torque was mislabeled on the packaging.
2019-04-02Ortho Organizers, Inc.Orthodontic Bracket is mislabeled
2019-04-02Ortho Organizers, Inc.Orthodontic Bracket is mislabeled
2014-03-25Ormco/SybronendoOrmco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the
2013-02-08Ultradent Products, Inc.Orthodontic brackets distributed was incorrectly labeled.
2012-04-24Ormco/SybronendoThe firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicuspid Brackets are produced with a purple colored ID dot to ident
2009-02-13Ormco CorporationThe recall was initiated because Ormco has confirmed that manufacturing error resulted in the Orthos CM Brackets being incorrectly manufactured with a torque of
2004-11-18Ormco CorporationMisassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.