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SI

Shinhung MST Co., Ltd. · Model SDAR6051H · UDI-DI 08809457209736

NHA Prescription

510(k) clearances

8,407

Adverse events (1 deaths)

225

Recalls

378

Facilities

Description

Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s 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.