DIO PROTEM IMPLANT SYSTEMS
DIO Corporation · Model MBC 3803 · UDI-DI 08800049251157
Description
The DIO Protem Implant System consist of Dental Implant, Superstructure, Prosthetics and Surgical Instruments. The Protem Implants is an integrated system of endosseous dental implants which increas indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sand-blasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implant which provide the clinician to maintain the patients` gingival contour. The Implants have the diameter(2.0/2.5mm) and length(8/10/12/14mm). The superstructures consist of Ball Cap. Ball Cap intended to retain the O-ring inside of the denture. The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation. The Implants are gamma sterilized and intended to single use. And the others and non-gamma stereilized and have to be sterilized by user before using.
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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