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ST

Shinhung MST Co., Ltd. · Model STSPAR40 · UDI-DI 08809458315368

NHA Prescription

510(k) clearances

8,407

Adverse events (1 deaths)

225

Recalls

378

Facilities

Description

The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.

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.