Elos Accurate Hybrid Base Engaging
Elos Accurate Hybrid Base Engaging is a titanium-alloy interface between a dental implant and a patient-specific ceramic superstructure. The base and zirconia upper portion together form…
Elos Accurate Hybrid Base Engaging is a titanium-alloy interface between a dental implant and a patient-specific ceramic superstructure. The base and zirconia upper portion together form the finished hybrid abutment.
A prosthetic screw attaches the base to the compatible implant. The laboratory designs the zirconia superstructure digitally, manufactures it through the specified workflow and cements it to the base.
Listed Item
The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and to support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented to the base. The base and the superstructure form a patient-specific abutment that will support a definitive restoration, either a single crown or a multi-unit restoration. The Elos Accurate Hybrid Base Engaging is intended for single-unit restorations and Elos Accurate Hybrid Base Non-Engaging is intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the Elos Accurate Hybrid Base.
Materials and Preparation
The base uses Ti-6Al-4V ELI titanium alloy with a gold-coloured anodized surface. Screw coating depends on the implant-platform configuration. Components are delivered nonsterile, and the completed restoration and corresponding screw require sterilization at the dental clinic before placement.
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 | Elos Medtech Pinol A/S, Denmark |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K230317 |
| Record published | 2023-10-03 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HBE-ZSV57-1 | In distribution | |
| HBE-NBR50-1 | In distribution | |
| HBE-BRA41-1 | In distribution | |
| HBE-NBR60-1 | In distribution | |
| HBE-ATO30-1 | In distribution | |
| HBE-SBX45-1 | In distribution | |
| HBE-NBA35-1 | In distribution | |
| HBE-ATE36-1 | In distribution | |
| HBE-NBA60-1 | In distribution | |
| HBE-BRA51-1 | In distribution | |
| HBE-NBA43-1 | In distribution | |
| HBE-ATE54-1 | In distribution | |
| HBE-SSY48-1 | In distribution | |
| HBN-SBX45H-1 | In distribution | |
| HBE-ATE30-1 | In distribution | |
| HBE-ZSV45-1 | In distribution | |
| HBE-NGM45-1 | In distribution | |
| HBE-SSY65-1 | In distribution | |
| HBE-HET35-1 | In distribution | |
| HBE-NBR35-1 | In distribution | |
| HBE-ATO35/40-1 | In distribution | |
| HBE-BRA35-1 | In distribution | |
| HBE-ATE42-1 | In distribution | |
| HBE-SBO33-1 | In distribution | |
| HBE-NBA30H-1 | In distribution | |
| HBE-NBR43-1 | In distribution | |
| HBE-ZSV35-1 | In distribution | |
| HBE-SBO41/48-1 | In distribution | |
| HBE-NBA30-1 | In distribution | |
| HBE-HET45-1 | In distribution | |
| HBE-ATE48-1 | In distribution | |
| HBE-ATO45/50-1 | In distribution | |
| HBN-SBX45-1 | 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 |
|---|---|
| K253774 | 2026-05-20 |
| K251497 | 2025-10-16 |
| K242025 | 2024-12-10 |
| K241722 | 2024-09-13 |
| K231307 | 2023-12-21 |
| K230317 | 2023-09-01 |
| K222044 | 2022-11-30 |
| K201860 | 2021-02-19 |
| K191919 | 2020-02-10 |
| K191890 | 2020-02-06 |
| K192457 | 2020-01-02 |
| K190299 | 2019-06-26 |
| K171799 | 2018-01-15 |
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.