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Ceramic Lingual Button

G & H Wire Company, Inc. · Model CLB10 · UDI-DI 10190886010433

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The Freddy™ ceramic button is the perfect clear utility button for all aesthetic appliances. •Works lingually as well as labially •The Oral surgeons use them whenever clear appliances are indicated •Mesh structure of base makes a strong bonding •Bonds well with most common adhesives •Anatomy and size of base fits all teeth •Enough space around tie wing for all elastics •Maintains the transparent look with aligners as anchorage for elastics

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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Data 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.