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ERA® Micro IA Male Package (5)
STERNGOLD DENTAL LLC · Model 811127 · UDI-DI 00841549101045
EGG
Prescription
1
510(k) clearances
3
Adverse events
1
Recalls
57
Facilities
Description
Package contains 2 each- Black & White Micro ERA Overdenture males, and 1 orange 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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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.