Home › Device types › NDP
Accessories, Implant, Dental, Endosseous
FDA product code NDP · Class 1 · Dental
50,759
Registered devices
5,297
Adverse events
57
Recalls
4
510(k) clearances
Devices with this code
NA — Institut Straumann AGNA — SOUTHERN IMPLANTS (PTY) LTDNA — SOUTHERN IMPLANTS (PTY) LTDMIS — MIS Implants Technologies Ltd.NA — Institut Straumann AGNA — Institut Straumann AGTruLab Analog — Truabutment Korea Co.,LtdMagic Expander — InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)ITL — Preat CorporationNA — ZimVie US Corp LLCElos Accurate® Analog for Printed Models — Elos Medtech Pinol A/SNA — Nobel Biocare ABANKYLOS® — Dentsply Implants Manufacturing GmbHKLOCKNER — SOADCO, S.L.TruScan Post Kit — Truabutment Korea Co.,LtdEK NoMount Driver — Osstem Implant Co., Ltd.Multi Post Screw — Megagen Implant Co. LtdSET ZZ BASE DO-B-ICOTH RC (Impression coping open tray hex and Screw a — ZIRKONZAHN SRLStecoGuide — steco-System-Technik GmbH & Co KGInclusive® — Prismatik Dentalcraft, IncImplant-One — Implant Logistics, Inc.OT EQUATOR-OT BRIDGE — RHEIN 83 SRLKontact — BIOTECH DENTALTS Convertible Transfer Impression Coping — 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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