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ADITEK
ADITEK DO BRASIL S/A · Model 08.54.0205 · UDI-DI 07899439255487
8
510(k) clearances
25
Adverse events
4
Recalls
114
Facilities
Description
Buccal Tube Sgl Non-Conv Bond S Anatomic Base 022 Roth UL6/7 -10°T 8°O w/10
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-01-17 | Ormco/Sybronendo | The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal |
| 2020-01-17 | Ormco/Sybronendo | The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal |
| 2013-03-08 | Ormco/Sybronendo | Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the Bracket Buccal Tubes product package correct |
| 2010-11-01 | Ortho Organizers Inc | Products were mis-labeled as nickel free. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.