Elos Prosthetic Screw
Elos Prosthetic Screw secures a customized dental abutment to its compatible implant. The abutment then supports the prosthetic restoration, with the crown or coping attached to the…
Elos Prosthetic Screw secures a customized dental abutment to its compatible implant. The abutment then supports the prosthetic restoration, with the crown or coping attached to the abutment rather than directly to the screw.
The screw forms the mechanical fastening element of the implant-to-abutment connection. It is used within the specified Elos customized-abutment workflow.
Listed Item
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Preparation and Configuration
The finished restoration and corresponding screw are supplied for sterilization at the dental clinic before placement. Medicarb-coated screw configurations are part of the described system. The screw and abutment interface must match the implant platform selected for the restoration.
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) | K171799 |
| Record published | 2020-03-31 |
| Record revised | 2020-09-22 (version 2) |
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 |
|---|---|---|
| AS-BRAM167POS | In distribution | |
| AS-MUAM1403POS | In distribution | |
| AS-MUAM1804POS | In distribution | |
| AS-BRAM2007A-1 | In distribution | |
| AS-SBOM1608POS | In distribution | |
| AS-BCEM168NCPOS | In distribution | |
| AS-NGMM1610POS | In distribution | |
| AS-NBAM1407POS | In distribution | |
| AS-HETM1610POS | In distribution | |
| AS-ATOM148POS | In distribution | |
| AS-NBAM168POS | In distribution | |
| AS-BRAM207POS | In distribution | |
| AS-ATEM208POS | In distribution | |
| AS-ATEM148POS | In distribution | |
| AS-SSYM207POS | In distribution | |
| AS-SBXM1606POS | In distribution | |
| AS-BRAM1607A-1 | In distribution | |
| AS-ATEM188POS | In distribution | |
| AS-ATOM2010POS | In distribution | |
| AS-HETM2008POS | In distribution | |
| AS-BRAM257POS | In distribution | |
| AS-NBRM1808POS | In distribution | |
| AS-NBRM2010POS | In distribution | |
| AS-ATOM168POS | In distribution | |
| AS-ATEM168POS | In distribution | |
| AS-NBAM207POS | In distribution | |
| AS-ZSVM1808POS | In distribution | |
| AS-BRAM2507A-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.