Home › Device types › DYW
Bracket, Plastic, Orthodontic
FDA product code DYW · Class 2 · Dental
1,789
Registered devices
45
Adverse events
5
Recalls
42
510(k) clearances
Devices with this code
Comp Plus "T"™ LL Cuspid Roth .018 — ORTHO SPECIALTIESEnvision — Ortho Organizers, Inc.Quantum — Ortho Organizers, Inc.Reflections® — Ortho Organizers, Inc.Sierra Cosmetic Brackets — AMERICAN ORTHODONTICS CORPORATIONOrthoFlex — ORTHO TECHNOLOGY, INC.Envision — Ortho Organizers, Inc.Carriere — Ortho Organizers, Inc.Silkon Plus — AMERICAN ORTHODONTICS CORPORATIONOrthoFlex — ORTHO TECHNOLOGY, INC.Hyrax — DENTAURUM GmbH & Co.KGQuantum — Ortho Organizers, Inc.Sierra Classic — AMERICAN ORTHODONTICS CORPORATIONN/A — FlexmedicsOrthoFlex — ORTHO TECHNOLOGY, INC.Damon 3 — ORMCO CORPORATIONCarriere® Motion Pro™ — Ortho Organizers, Inc.Reflections® — Ortho Organizers, Inc.Sierra Cosmetic Brackets — AMERICAN ORTHODONTICS CORPORATIONPRISM™ MBT COMPOSITE BRACKETS — G & H Wire Company, Inc.APC™ II Unitek™ Gemini Clear — 3M UNITEK CORPORATIONLUCENT™ EDGEWISE METAL LINED COMPOSITE BRACKETS (KIT) — G & H Wire Company, Inc.Comp Plus Six™ 1 Case Bracket Kit-Lab Use — ORTHO SPECIALTIESAPC™ II Unitek™ Gemini Clear — 3M UNITEK CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-03-25 | Ormco/Sybronendo | Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 081351013, because the ID dot, which designates the bracket as d |
| 2011-05-18 | Ormco Corporation | Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error. |
| 2011-05-18 | Ormco Corporation | Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error. |
| 2005-11-03 | Ormco Corporation | Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance. |
| 2005-11-03 | Ormco Corporation | Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance. |
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