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SM INTERNAL/EXTERNAL IMPLANT SYSTEMS

DIO Corporation · Model RBN 40412 · UDI-DI 08800049273623

NDP Prescription

510(k) clearances

4,902

Adverse events

Recalls

530

Facilities

Description

SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 3.8, 4.5 and 5.3mm, and lengths from 8mm to 14mm. It is placed via one or two stage surgery and the functional loading can be from immediated to delay.

Recalls

Date	Firm	Reason
2026-01-06	Straumann USA LLC	The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
2025-07-24	Dentsply IH, Inc.	The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage appr
2025-07-24	Dentsply IH, Inc.	The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage appr
2025-04-14	Prismatik Dentalcraft, Inc.	Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
2025-03-08	Straumann USA LLC	The devices are missing the laser marked depth markings.
2024-06-25	Preat Corp	Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.
2024-01-24	Thommen Medical AG	The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
2023-12-27	TruAbutment Inc.	Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
2021-07-26	Paltop Advanced Dental Solutions Ltd	Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size eng
2021-07-26	Paltop Advanced Dental Solutions Ltd	Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size eng

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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.