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VAPOR™ ROTH CERAMIC BRACKETS
G & H Wire Company, Inc. · Model 75-U4-8RK-V · UDI-DI 10190886007754
NJM
Prescription
1
510(k) clearances
23
Adverse events
1
Recalls
47
Facilities
Description
VAPOR™ ROTH .018 UR4/5 HK -7°T 0°A Vapor™ brackets are nearly invisible polycrystalline Ceramic Brackets manufactured through Ceramic Injected Molded – (CIM) Manufacturing. They are translucent in appearance, and aesthetically pleasing. They have a revolutionary "Portal" Bonding Base; so adhesive flows through portals in the base for unprecedented mechanical bonds and optimal debonds.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-11-19 | Ultradent Products, Inc. | Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution. |
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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.