UF(II) Bar Holder Abutment
The UF(II) Bar Holder Abutment connects dental implant fixtures to a bar-retained overdenture. It is intended for multi-unit restorations in the upper or lower jaw, including patients with…
The UF(II) Bar Holder Abutment connects dental implant fixtures to a bar-retained overdenture. It is intended for multi-unit restorations in the upper or lower jaw, including patients with partial or complete tooth loss.
A bar is held in the abutment assembly by a set screw, and clips fixed into the overdenture retain the denture on the bar. The abutments are made from Ti-6Al-4V ELI titanium alloy.
Listed Item
The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients.
Abutment Configurations
Single-body configurations contain an abutment, abutment screw and set screw. Cap-type configurations add an abutment cap. Both offer hexagonal and non-hexagonal connection versions. The system includes the bar and retention clips, and its components are supplied nonsterile for steam sterilization before use.
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (2), Shanghai (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Exceldent Dental Technology Development Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 12 |
| DTS Digital Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 11 |
| KTJ Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shimmer Computerized Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 10 |
| Zhuhai Crystal Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 9 |
| NEW Perfect Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| CBD Dental LAB, Inc | Shenzhen | Guangdong | Manufacturer | 11 |
Showing 12 of 15. All 15 manufacturers in China registered for Abutment, Implant, Dental, Endosseous
Record
| Listed by | DIO Corporation, South Korea |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K193404 |
| Record published | 2022-03-01 |
| Record revised | 2022-02-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature 1 to 30 °C |
| Distribution end date | 2022-02-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UNMBHCA 4509N | In distribution | |
| UNMBHA 4509N | In distribution | |
| MBHCA 4509N | In distribution | |
| MBHCA 4507N | In distribution | |
| MBHA 4508N | In distribution | |
| UNMBHCA 4507N | In distribution | |
| UNMBHA 4506N | In distribution | |
| MBHCA 4508N | In distribution | |
| MBHA 4509N | In distribution | |
| MBHA 4507N | In distribution | |
| UNMBHA 4507N | In distribution | |
| UNMBHCA 4508N | In distribution | |
| MBHA 4506N | In distribution | |
| UNMBHA 4508N | In distribution | |
| UNMBHCA 4506N | In distribution | |
| MBHCA 4506N | In distribution | |
| UNMBHCA 4507N | Withdrawn | |
| MBHCA 4509N | Withdrawn | |
| UNMBHCA 4509N | Withdrawn | |
| MBHCA 4507N | Withdrawn | |
| UNMBHCA 4506N | Withdrawn | |
| MBHCA 4508N | Withdrawn | |
| UNMBHCA 4508N | Withdrawn | |
| MBHCA 4506N | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MEDENTiKA | Medentika GmbH | 2,553 |
| LW Vis Abutment | Ossvis Co., Ltd. | 2,520 |
| Dess dental smart solutions | Terrats Medical SL | 1,715 |
| Locator | Zest Anchors, LLC | 1,643 |
| NobelProcera® | Nobel Biocare AB | 1,526 |
| Azure | Terrats Medical SL | 1,360 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 1,308 |
| LW Vis Abutment SET | Ossvis Co., Ltd. | 1,260 |
| Abutment, Implant, Dental, Endosseous | Southern Implants (PTY) Ltd | 1,240 |
| Healing Abutment | Megagen Implant Co., Ltd. | 1,218 |
| Chaorum Implant System | Medimecca Co Ltd | 1,084 |
| OT Equator | Rhein 83 SRL | 1,051 |
Showing 12 of 6,204. All products under Abutment, Implant, Dental, Endosseous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220253 | 2023-08-18 |
| K193404 | 2020-05-18 |
| K192263 | 2020-02-21 |
| K190048 | 2019-09-30 |
| K181037 | 2018-12-21 |
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.