NizPlant™ Implant
NizPlant is a titanium alloy dental implant for single-stage placement in partially or fully edentulous jaws. It supports complete dentures or fixed or removable multi-unit bridgework. The…
NizPlant is a titanium alloy dental implant for single-stage placement in partially or fully edentulous jaws. It supports complete dentures or fixed or removable multi-unit bridgework. The design includes a straight machined neck, a dual-function restorative platform and a tapered threaded lower body.
Two cutting grooves provide a self-tapping function. The platform can support attachment-retained overdentures or screw-retained prostheses. Implant diameters range from 3.0 to 5.7 mm, with a 3.9 mm external platform and different lengths to match the restorative configuration.
Listed Item
NizPlant Imp. 4.7mmD-12.5mmL-3.9mmP
Loading and Surface
Immediate function requires initial implant stability and appropriate occlusal loading. Short implants under 9 mm are intended for multiple-unit restorations where vertical bone is limited. The coronal region is partly gold-anodized, while a blasted portion provides microtexture. The implants are supplied sterile.
Who Else Makes It
Concentrated in Jiangsu (3), Sichuan (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Basic (Chengdu) Medical Device Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 1 |
| Dongguan Xinlonghong Hardware Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| BIO Concept Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Paragon Implant MFG., LLC, United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K250476 |
| Record published | 2026-01-08 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 3 to 5.7 mm; length 7 to 14 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NP4712 | Outer Diameter 4.7 mm | In distribution |
| NP4209 | Outer Diameter 4.2 mm | In distribution |
| NP5207 | Outer Diameter 5.2 mm | In distribution |
| NP3014 | Outer Diameter 3.0 mm | In distribution |
| NP4709 | Outer Diameter 4.7 mm | In distribution |
| NP4707 | Outer Diameter 4.7 mm | In distribution |
| NP4211 | Outer Diameter 4.2 mm | In distribution |
| NP5209 | Outer Diameter 5.2 mm | In distribution |
| NP5211 | Outer Diameter 5.2 mm | In distribution |
| NP5711 | Outer Diameter 5.7 mm | In distribution |
| NP4711 | Outer Diameter 4.7 mm | In distribution |
| NP3711 | Outer Diameter 3.7 mm | In distribution |
| NP5709 | Outer Diameter 5.7 mm | In distribution |
| NP5214 | Outer Diameter 5.2 mm | In distribution |
| NP4212 | Outer Diameter 4.2 mm | In distribution |
| NP3712 | Outer Diameter 3.7 mm | In distribution |
| NP5212 | Outer Diameter 5.2 mm | In distribution |
| NP3012 | Outer Diameter 3.0 mm | In distribution |
| NP5707 | Outer Diameter 5.7 mm | In distribution |
| NP3707 | Outer Diameter 3.7 mm | In distribution |
| NP3709 | Outer Diameter 3.7 mm | In distribution |
| NP3714 | Outer Diameter 3.7 mm | In distribution |
| NP3011 | Outer Diameter 3.0 mm | In distribution |
| NP4207 | Outer Diameter 4.2 mm | In distribution |
| NP4714 | Outer Diameter 4.7 mm | In distribution |
| NP5712 | Outer Diameter 5.7 mm | In distribution |
| NP4214 | Outer Diameter 4.2 mm | In distribution |
| NP3009 | Outer Diameter 3.0 mm | In distribution |
| NP5714 | Outer Diameter 5.7 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 920 |
| Osstem Implant System | Osstem Implant Co., Ltd. | 788 |
| Magicore | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 744 |
| Implant, Endosseous, Root-Form | Southern Implants (PTY) Ltd | 608 |
| ITL Dental | Emery Enterprises Inc. | 603 |
| Magicore S | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 560 |
| Friadent® | Dentsply Implants Manufacturing GmbH | 525 |
| Sphero Block Normo | Rhein 83 SRL | 489 |
| Neobiotech Implant System | Neobiotech Co., Ltd. | 483 |
| KJ Mini Implant System | Kjmeditech.co., Ltd. | 448 |
| Ritter Dental Implant System | Ritter Implants GmbH & Co. KG | 418 |
| Leone SPA | Leone SPA | 404 |
Showing 12 of 2,762. All products under Implant, Endosseous, Root-Form
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250476 | 2025-12-23 |
| K252145 | 2025-12-23 |
| K251938 | 2025-10-30 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P800035 | 2001-10-04 | PERI-OSS | Curasan AG |
| P860012 | 1988-10-28 | ALVEOFORM TM BIOGRAFT | Collagen Corp. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.