I-FIX Angled Type Fixture Healing Abutment
The I-FIX Angled Type Fixture Healing Abutment protects the internal opening of a compatible dental implant fixture during healing. It also establishes the appropriate height for that…
The I-FIX Angled Type Fixture Healing Abutment protects the internal opening of a compatible dental implant fixture during healing. It also establishes the appropriate height for that healing phase as an aid to prosthetic rehabilitation.
The abutment body is made from commercially pure Grade 4 titanium and is secured with a separate titanium alloy screw. The healing abutment has no surface coating and is supplied in different heights to fit the required configuration.
Listed Item
I-FIX Angled Type Fixture Healing Abutment / DMAHA4050NS
Compatibility and Supply
It is compatible with the I-FIX System’s angled type fixtures in the specified 2.0, 2.5 and 3.0 mm diameter range. The healing abutment and its screw are packaged together and supplied gamma sterile.
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 | Dentis Co., Ltd., South Korea |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K230203 |
| Record published | 2023-05-08 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DMAHA4040N | In distribution | |
| DMAHA4050NS | In distribution | |
| DMAHA4040NS | In distribution | |
| DMAHA4070N | In distribution | |
| DMAHA4070NS | In distribution | |
| DMAHA4050N | In distribution | |
| DMAHA4032N | In distribution | |
| DMAHA4032NS | In distribution |
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 |
|---|---|
| K241063 | 2024-07-25 |
| K230126 | 2023-08-04 |
| K230307 | 2023-07-11 |
| K230246 | 2023-05-25 |
| K230523 | 2023-05-24 |
| K230203 | 2023-05-03 |
| K222451 | 2023-02-07 |
| K222913 | 2023-01-13 |
| K222976 | 2023-01-12 |
| K220440 | 2022-06-16 |
| K210410 | 2021-09-10 |
| K210362 | 2021-08-19 |
| K171694 | 2017-11-29 |
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.