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Vatech Clismile
Rayence Co., Ltd. · Model 21-1234 · UDI-DI 08800018601136
EJF
Prescription
10
510(k) clearances
148
Adverse events
8
Recalls
160
Facilities
Description
This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
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 wrong tie-wing of t |
| 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 identify them as maxillar |
| 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 -9. The packaging w |
| 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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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.