Tissue Punch - 4.2mm
3D DIAGNOSTIX, INC. · Model Dental soft-tissue coring punch, reusable / Tissue Punch - 4.2mm · UDI-DI 00850073333556
Description
A dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Sometimes referred to as a mucotome, it will typically be designed with a handle at the proximal end for manual operation or for mounting into a dental power tool (e.g., contra-angle low-speed drill handpiece), and have a cylindrical hollow tube-like head with a sharp cutting at the distal end. It is typically made of high-grade stainless steel. This is a reusable device.
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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