DIO PROTEM IMPLANT SYSTEMS
DIO Corporation · Model MAP 3010 · UDI-DI 08800049273517
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 |
|---|---|---|
| 2026-01-06 | 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs