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
Mini Sprint® — Forestadent Bernhard Förster GmbHOMNIARCH® — DENTSPLY SIRONA ORTHODONTICS INC.Tip-Edge PLUS Stainless Steel Brackets — TP ORTHODONTICS INC3M™ Unitek™ Victory Series™ — 3m do Brasil Ltda.Easter S.L Bracket, .022 Roth, LR1 — Astar Orthodontics Inc.ADITEK — ADITEK DO BRASIL S/ALEONE SPA — LEONE SPAMini-Sprint® — Forestadent Bernhard Förster GmbHBioQuick® — Forestadent Bernhard Förster GmbHLEGEND — Gc Orthodontics America Inc.discovery® — DENTAURUM GmbH & Co.KGMini-Sprint® — Forestadent Bernhard Förster GmbHH4 — World Class Technology CorporationILLUSION PLUS INTERNATIONAL — Ortho Organizers, Inc.Nickel-Free Mini-Twin — Ortho Organizers, Inc.Votion® — Ortho Organizers, Inc.Mini Master Series — AMERICAN ORTHODONTICS CORPORATIONYoung Specialties — Young Innovations, Inc.The Orthodontic Store — Young Innovations, Inc.LEONE SPA — LEONE SPALEONE SPA — LEONE SPABuccal Tube — Gc Orthodontics America Inc.Bondable Buccal — Gc Orthodontics America Inc.Ovation® — DENTSPLY SIRONA ORTHODONTICS INC.
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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