Link Abutment for Cerec
Link Abutment for CEREC connects a customized dental restoration to a compatible HIOSSEN implant. The stock titanium-alloy base supports screw-retained single-tooth restorations or…
Link Abutment for CEREC connects a customized dental restoration to a compatible HIOSSEN implant. The stock titanium-alloy base supports screw-retained single-tooth restorations or cement-retained single-tooth and bridge restorations. Its coronal portion interfaces with the premachined mounting hole in a compatible milling blank.
The restoration workflow uses Sirona CEREC AC, AF or AI scanning, followed by inLab 3.65 or CEREC 4.2 design software and a CEREC or inLab MC X or MC XL milling unit. Milling takes place in a dental laboratory within the system’s design limits.
Connection and Preparation
The implant interface uses an 11-degree Morse-taper internal connection with mini or regular hex and non-hex options. The abutment and superstructure require gravity-displacement steam sterilization at 132 degrees Celsius for fifteen minutes, followed by fifteen minutes of drying 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 | Osstem Implant Co., Ltd., South Korea |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K160519 |
| Record published | 2017-03-31 |
| Record revised | 2019-11-08 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HGCTBRHW | In distribution | |
| HGCTBMNW | In distribution | |
| HGCTBMHW | In distribution | |
| HGCTBRNW | 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 |
|---|---|
| K251434 | 2026-03-04 |
| K233194 | 2024-02-20 |
| K232220 | 2023-12-05 |
| K221684 | 2022-09-08 |
| K182091 | 2019-07-12 |
| K161689 | 2017-05-22 |
| K160670 | 2017-04-25 |
| K153015 | 2016-12-05 |
| K160519 | 2016-10-28 |
| K140600 | 2014-08-21 |
| K140507 | 2014-08-20 |
| K130662 | 2014-01-10 |
| K123755 | 2013-04-26 |
| K121843 | 2012-12-11 |
| K110308 | 2011-10-03 |
| K100245 | 2010-08-17 |
| K081786 | 2008-12-02 |
| K081575 | 2008-09-02 |
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.