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ERA® Micro 17° DO Small Post Female SS

STERNGOLD DENTAL LLC · Model 811437 · UDI-DI 00841549102011

NHA Prescription

510(k) clearances

8,407

Adverse events (1 deaths)

225

Recalls

378

Facilities

Description

This part contains: 1 female 1.3mm post diameter, 9mm long. These attachments are placed in the retained tooth root, which has been prepared to receive the fixed attachment component. The other component of the attachment becomes part of a patient removable overdenture, which is a denture partially supported by one or more retained roots. ERA Direct Placement Overdenture is available in standard and micro sizes. This product consist of a stainless steel female with a titanium nitride coating and a choice of four different post angles – 0° (straight), 5°, 11° and 17°, and two post diameters – 1.3mm and 1.7mm, both 9mm long. Six color coded males to create a consistent level of retention (white, orange, blue, grey, yellow, red). An optional metal jacket is also available to hold the attachment male in the denture base and is sold pre-loaded with a black fabrication male. Intended to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function.

Recalls

Date	Firm	Reason
2026-07-13	Straumann USA LLC	There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the i
2026-03-27	Straumann USA LLC	Includes an incorrect screw seat interface.
2026-03-27	Straumann USA LLC	Includes an incorrect screw seat interface.
2026-03-17	Straumann USA LLC	A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorre
2026-03-17	Straumann USA LLC	A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorre
2025-09-30	Prismatik Dentalcraft, Inc.	Incorrect titanium screw, packaged with dental implant.
2025-06-25	Preat Corp	Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the
2025-06-24	Preat Corp	Due to manufacturing error, digital analog rotational feature is 180 degrees off.
2025-04-17	Straumann USA LLC	Incorrect blister labelling.
2025-04-02	Preat Corp	Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the ass

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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.