Home › Device types › DYW
Bracket, Plastic, Orthodontic
FDA product code DYW · Class 2 · Dental
3,795
Registered devices
45
Adverse events
5
Recalls
42
510(k) clearances
Devices with this code
OrthoFlex™ — Ortho Organizers, Inc.N/A — FlexmedicsN/A — FlexmedicsPremium Line — EC Certification Service GmbHPremium Line — EC Certification Service GmbHPremium Line — EC Certification Service GmbHELATION® MB — DENTSPLY SIRONA ORTHODONTICS INC.ELATION® MB — DENTSPLY SIRONA ORTHODONTICS INC.Premium Line — EC Certification Service GmbHPremium Line — EC Certification Service GmbH.022 Universal Bicuspid Comp Clear Six™ — ORTHO SPECIALTIESLucid-Lok™ — Six Month SmilesOrthoFlex™ — Ortho Organizers, Inc.Premium Line — EC Certification Service GmbHPremium Line — EC Certification Service GmbHPremium Line — EC Certification Service GmbHN/A — FlexmedicsOrthoFlex — ORTHO TECHNOLOGY, INC.Sierra Cosmetic Brackets — AMERICAN ORTHODONTICS CORPORATIONPremium Line — EC Certification Service GmbHAvalon — ORTHO TECHNOLOGY, INC.Alexander SpiritMB — ORMCO CORPORATIONComp Plus "T"™ UL Cuspid Roth .022 — ORTHO SPECIALTIESAlice — Rmo, Inc.
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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