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ERA® Micro Partial Males White (5)

STERNGOLD DENTAL LLC · Model 811014 · UDI-DI 00841549100697

EGG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

White final male. Attachments are two-part connectors. One part is intraorally fixed as part of a fixed (i.e. not patient removable) dental restoration, and a replaceable, high density nylon male anchored into a patient removable dental prosthesis (denture base). When the removable prosthesis is seated in the mouth the attachment parts come together and secure it in place. In other applications the attachment connects two sections of a segmented fixed partial denture.

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.