Home › Device types › NDP
Accessories, Implant, Dental, Endosseous
FDA product code NDP · Class 1 · Dental
49,883
Registered devices
4,902
Adverse events
57
Recalls
4
510(k) clearances
Devices with this code
ET RIGID RETRACTION CAP — HIOSSEN, INC.Inclusive® — Prismatik Dentalcraft, IncWP CloseFit™ Close Tray Transfer Screw Short — ADIN DENTAL IMPLANT SYSTEMS LTDTwist drill — CARMEX PRECISION TOOLS LIMITEDOmnigrip™ — Nobel Biocare ABNobel Biocare® — Nobel Biocare ABNA — Institut Straumann AGN/A — SOUTHERN IMPLANTS (PTY) LTDNA — Nobel Biocare ABNA — Nobel Biocare ABNobel Biocare® — Nobel Biocare ABNobelProcera® — Nobel Biocare ABNA — Institut Straumann AGNeodent — JJGC Indústria e Comércio de Materiais Dentários S/A.Intraoral Scan Body WP — RP - CONEXOES RESTAURADORAS LTDASingle Guide — Osstem Implant Co., Ltd.Fixture Remove Clamp Adapter Long — WARANTEC.Co.,LtdOpen Tray Impression Transfer — Surgikor, LLCMEDENTiKA — MEDENTiKA GmbHShaping Drill — Megagen Implant Co. LtdGlidewell HT™ — Prismatik Dentalcraft, IncElos Accurate® Model Analog — Elos Medtech Pinol A/SDriver Shaft for Screwdriver Handle — Izenimplant Co., Ltd.Single Guide — Osstem Implant Co., Ltd.
Recent 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 w |
| 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 w |
| 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 |
| 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 |
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