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DENTAL ATTACHMENTS

RHEIN 83 SRL · Model OT CAP STANDARD size · UDI-DI 08059224001050

EGG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

KIT containing - single spheres: SINGLE USE castable device to be transformed via casting technique in a metal attachment for removable prosthesis. - pink retentive caps: DISPOSABLE device in plastic material to be embodied in a removable prosthesis. Cap with soft retention. - stainless steel housings: DISPOSABLE device used to contain the retentive cap inside the removable prosthesis. - plastic positioners: SINGLE USE plastic device. Centering ring 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.