Arum NB 1 SA Fixture
The ARUM NB 1 SA Fixture is a dental implant body placed in the jawbone to support replacement teeth. It is used in partially or fully edentulous upper or lower jaws with single or…
The ARUM NB 1 SA Fixture is a dental implant body placed in the jawbone to support replacement teeth. It is used in partially or fully edentulous upper or lower jaws with single or multiple-unit restorations, including crowns, bridges and overdentures. It is part of a two-stage implant system.
The threaded fixture is made of commercially pure grade 4 titanium. Its surface is sandblasted with large grit and acid etched. A compatible abutment connects the fixture to the dental prosthesis, while an internal hex connection provides an anti-rotation interface.
Loading and Supply
Immediate loading is permitted when good primary stability and an appropriate occlusal load are achieved. Fixtures greater than 5 mm in diameter are indicated for molar sites. The fixture is supplied sterile with a cover screw.
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 | Arum Dentistry Co., Ltd., South Korea |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Manufacturer |
| 510(k) | K213506 |
| Record published | 2022-06-08 |
| Record revised | 2022-07-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NB16007SS | In distribution | |
| NB16511S | In distribution | |
| NB16006SP | In distribution | |
| NB16013S | In distribution | |
| NB14010S | In distribution | |
| NB16513S | In distribution | |
| NB15008SS | In distribution | |
| NB16011S | In distribution | |
| NB15010SP | In distribution | |
| NB15010S | In distribution | |
| NB16006SS | In distribution | |
| NB13811S | In distribution | |
| NB14013S | In distribution | |
| NB16013SP | In distribution | |
| NB13811SP | In distribution | |
| NB16006S | In distribution | |
| NB13813SP | In distribution | |
| NB14508SS | In distribution | |
| NB15008SP | In distribution | |
| NB15511SP | In distribution | |
| NB15513S | In distribution | |
| NB15507SS | In distribution | |
| NB16010S | In distribution | |
| NB15510SS | In distribution | |
| NB15511SS | In distribution | |
| NB14511S | In distribution | |
| NB15507S | In distribution | |
| NB13813S | In distribution | |
| NB14510S | In distribution | |
| NB14510SS | In distribution | |
| NB16007S | In distribution | |
| NB16513SP | In distribution | |
| NB16008S | In distribution | |
| NB15007SS | In distribution | |
| NB15011SS | In distribution | |
| NB16506S | In distribution | |
| NB14010SS | In distribution | |
| NB14007SP | In distribution | |
| NB14007S | In distribution | |
| NB13810SP | In distribution | |
| NB16010SP | In distribution | |
| NB15007SP | In distribution | |
| NB15506S | In distribution | |
| NB16513SS | In distribution | |
| NB15013S | In distribution | |
| NB13813SS | In distribution | |
| NB13810S | In distribution | |
| NB14507SS | In distribution | |
| NB14008S | In distribution | |
| NB14507SP | In distribution | |
| NB15508S | In distribution | |
| NB15506SS | In distribution | |
| NB14513S | In distribution | |
| NB14008SP | In distribution | |
| NB13808S | In distribution | |
| NB14508S | In distribution | |
| NB15010SS | In distribution | |
| NB15510SP | In distribution | |
| NB16007SP | In distribution | |
| NB15513SP | In distribution | |
| NB14511SS | In distribution | |
| NB15011S | In distribution | |
| NB14011SP | In distribution | |
| NB16506SS | In distribution | |
| NB16511SS | In distribution | |
| NB14510SP | In distribution | |
| NB16510S | In distribution | |
| NB15013SS | In distribution | |
| NB13808SS | In distribution | |
| NB14013SP | In distribution | |
| NB16508SS | In distribution | |
| NB16508S | In distribution | |
| NB14007SS | In distribution | |
| NB16011SP | In distribution | |
| NB13808SP | In distribution | |
| NB15007S | In distribution | |
| NB14010SP | In distribution | |
| NB13811SS | In distribution | |
| NB14513SP | In distribution | |
| NB14511SP | In distribution | |
| NB15008S | In distribution | |
| NB16013SS | In distribution | |
| NB14513SS | In distribution | |
| NB16506SP | In distribution | |
| NB16507SS | In distribution | |
| NB14008SS | In distribution | |
| NB16008SP | In distribution | |
| NB16011SS | In distribution | |
| NB15508SS | In distribution | |
| NB16008SS | In distribution | |
| NB16010SS | In distribution | |
| NB16508SP | In distribution | |
| NB15511S | In distribution | |
| NB16507SP | In distribution | |
| NB14507S | In distribution | |
| NB15506SP | In distribution | |
| NB15013SP | In distribution | |
| NB15507SP | In distribution | |
| NB14011S | In distribution | |
| NB15011SP | In distribution | |
| NB15508SP | In distribution | |
| NB16510SS | In distribution | |
| NB13810SS | In distribution | |
| NB14508SP | In distribution | |
| NB14013SS | In distribution | |
| NB15510S | In distribution | |
| NB16511SP | In distribution | |
| NB16510SP | In distribution | |
| NB14011SS | In distribution | |
| NB15513SS | In distribution | |
| NB16507S | 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 |
|---|---|
| K250280 | 2025-07-23 |
| K241703 | 2025-02-24 |
| K242753 | 2025-01-06 |
| K240091 | 2024-04-26 |
| K230725 | 2023-07-01 |
| K222131 | 2022-09-19 |
| K213506 | 2022-04-06 |
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.