DIO SM IMPLANT SYSTEM
DIO Corporation · Model SAHN 4113 · UDI-DI 08806195922293
Description
The DIO SM Implant System is comprised of dental implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO SM Implant System is specially designed for use in dental implant surery. A successfully osseointegrated implant willl achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edendulous mandibles and maxillae, in support of single or multiple-unit restorations. The superstructures consist of screws(Closing Screw, Coping Screw), abutments(Screw retained type, Cemented retained type, Overdenture retained type), Solid protect cap. The screws are made of commercial pure titanium, grade 4(ASTM F67) and Ti-6A1-4VELI(ASTM F136) intended to be used in a narrow tooth gap after implant insertion and to protect exposed top of the implant or to attach the abutment to implant. The abutments are made or commercial pure titanium, grade 3 and grade(ASTM F67), Ti-6A1-4VELI(ASTM F136), white gold alloy, POM, PMMA. The intentions of each abutment are described in part 2.4. The protect cap is made of POM and intended to protect infecting other substances after solid abutment is fixed on the implant.
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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