Home › Device types › EJF
Bracket, Metal, Orthodontic
FDA product code EJF · Class 1 · Dental
37,947
Registered devices
148
Adverse events
8
Recalls
103
510(k) clearances
Devices with this code
BioPassive® — Forestadent Bernhard Förster GmbHORTHOMETRIC ULTRA-P BRACKET — ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECLIPSE INTERACTIVE — Ortho Arch Company IncMini Sprint® — Forestadent Bernhard Förster GmbHBioQuick® — Forestadent Bernhard Förster GmbHT3 — AMERICAN ORTHODONTICS CORPORATIONEmpower Bracket — AMERICAN ORTHODONTICS CORPORATIONMaster Series — AMERICAN ORTHODONTICS CORPORATIONEmpower Bracket — AMERICAN ORTHODONTICS CORPORATIONN.A. — DENTAURUM GmbH & Co.KGBionic — ORTHO TECHNOLOGY, INC.Lotus Plus DS — ORTHO TECHNOLOGY, INC.MICROARCH® — DENTSPLY SIRONA ORTHODONTICS INC.Sprint® — Forestadent Bernhard Förster GmbHMicro Twin Bracket — Ortho Arch Company Inc3M™ Unitek™ Victory Series™ MBT™ — 3M UNITEK CORPORATIONLEGEND — Gc Orthodontics America Inc.Mini-Mono® — Forestadent Bernhard Förster GmbHMini-Mono® — Forestadent Bernhard Förster GmbHequilibrium® — DENTAURUM GmbH & Co.KGCarriere — Ortho Organizers, Inc.Votion® — Ortho Organizers, Inc.FLI Twin — Rmo, Inc.3M™ Unitek™ — 3m do Brasil Ltda.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-01-14 | Ormco/Sybronendo | The bracket torque was mislabeled on the packaging. |
| 2019-04-02 | Ortho Organizers, Inc. | Orthodontic Bracket is mislabeled |
| 2019-04-02 | Ortho Organizers, Inc. | Orthodontic Bracket is mislabeled |
| 2014-03-25 | Ormco/Sybronendo | Ormco 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 |
| 2013-02-08 | Ultradent Products, Inc. | Orthodontic brackets distributed was incorrectly labeled. |
| 2012-04-24 | Ormco/Sybronendo | The 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 |
| 2009-02-13 | Ormco Corporation | The recall was initiated because Ormco has confirmed that manufacturing error resulted in the Orthos CM Brackets being incorrectly manufactured with a torque of |
| 2004-11-18 | Ormco Corporation | Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed. |
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