Home › G & H Wire Company, Inc. › ZENITH™ ROTH COMPOSITE BRACKETS
ZENITH™ ROTH COMPOSITE BRACKETS
G & H Wire Company, Inc. · Model RCMLL523-V · UDI-DI 10190886009727
DYW
Prescription
1
510(k) clearances
45
Adverse events
5
Recalls
27
Facilities
Description
ZENITH™ ROTH CMP LWR LT 2ND BIC W/HK 022, -22°T, 0°A Zenith™ Series Composite [CM] aesthetic brackets are precision designed and manufactured so that no special treatment mechanics or bonding procedures are necessary. All of the same clinical techniques routinely used with metal brackets are applicable with Zenith™. Zenith™ brackets are designed with all the features needed to achieve contemporary treatment objectives including rounded contours for comfort and reduced friction, sweeping tie wing undercuts, notched bases for mechanical bonds, plus many more.
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 distal/gingival, is m |
| 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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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.