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DENTAL EQUIPMENTS

RHEIN 83 SRL · Model OT BAR MULTIUSE x USA · UDI-DI 08059224015682

EGG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

022OBB - SINGLE USE castable device: Bar with a retentive profile. 025CPB - SINGLE USE castable device. Prefabricated housing for bar. 023CPA - SINGLE USE castable device. Prefabricated positioner for castable box. 024CPB - SINGLE USE castable device. Prefabricated positioner for castable box. 027CRG - DISPOSABLE device in plastic material to be embodied in a removable prosthesis. Cap with average retention. 026CRR - DISPOSABLE device in plastic material to be embodied in a removable prosthesis. Clip with soft retention 027CRS - DISPOSABLE device in plastic material to be embodied in a removable prosthesis. Clip with extra soft retention 022RGO - SINGLE USE castable device. Prefabricated reinforcement bar. 155CC - SINGLE USE castable device Connector for castable housings

Recalls

Date	Firm	Reason
2008-01-10	Straumann Usa, Llc	Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diamete

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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.