Osstem Abutment System
Osstem Abutment System is a prosthetic component family that connects dental implant fixtures to crowns, bridges and overdentures. Different abutment designs provide the support and…
Osstem Abutment System is a prosthetic component family that connects dental implant fixtures to crowns, bridges and overdentures. Different abutment designs provide the support and connection needed for the selected restoration.
The family includes configurations for TS internal-hex, SS internal-octagon, US external-hex and MS narrow-ridge implants. These are separate connection options, and each abutment must correspond to its specified implant platform.
Restorative Designs
Transfer abutments support general cement-retained prostheses. Titanium alloy angled abutments include a 17 degree configuration for changing the prosthetic path, while other components serve healing or digital-restoration functions. The role depends on the selected abutment type.
15manufacturers in China registered for this device type
463catalogue numbers in this listing
18510(k) clearances naming this product code
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) | K182091 |
| Record published | 2023-05-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| USPTA3520M | In distribution | |
| TSPTA4010R | In distribution | |
| GSTA4732NWH | In distribution | |
| USPTA5010W | In distribution | |
| GSAA6040BWH | In distribution | |
| GSTA5670NWH | In distribution | |
| SSPTA4850R | In distribution | |
| GSTA5460NWH | In distribution | |
| GSTA7460NWH | In distribution | |
| USPTA4040R | In distribution | |
| USPTA3570M | In distribution | |
| GSTAS4671WH | In distribution | |
| GSAA4540NWH | In distribution | |
| GSTA4712NWH | In distribution | |
| GSTTA4510TH | In distribution | |
| USPTA5050W | In distribution | |
| TSMC500TH | In distribution | |
| GSTA6760NWH | In distribution | |
| GSTA5460WH | In distribution | |
| GS17MAS4850WH | In distribution | |
| GSTAS4671NWH | In distribution | |
| GSST3530R | In distribution | |
| GSTA7420NWH | In distribution | |
| GSTA4722NWH | In distribution | |
| GSTAS4761WH | In distribution | |
| MSPTC | In distribution | |
| GSST3540R | In distribution | |
| GSTAS4661NWH | In distribution | |
| GSTA4712WH | In distribution | |
| GSTA4752NWH | In distribution | |
| PTCEM06S | In distribution | |
| MTR200TH | In distribution | |
| USPTA4030R | In distribution | |
| GSTA4642NWH | In distribution | |
| TSPTA3510M | In distribution | |
| TSMTBS | In distribution | |
| GSTA4612NWH | In distribution | |
| TS10PA454MWH | In distribution | |
| GSTA4632NWH | In distribution | |
| TSPTA4060R | In distribution | |
| USPTA4010R | In distribution | |
| GSTTA4530NTH | In distribution | |
| TSMTB0405G | In distribution | |
| TS10PA455RWH | In distribution | |
| GSAA4520BWH | In distribution | |
| USPTA3530M | In distribution | |
| GSST3520R | In distribution | |
| SSPTA4830R | In distribution | |
| USPTA4010R | In distribution | |
| GSTA7410WH | In distribution | |
| GSTA5460NWH | In distribution | |
| GSTA7430NWH | In distribution | |
| PTCMC | In distribution | |
| GSTA4732WH | In distribution | |
| GSTA4762NWH | In distribution | |
| TSMN500TH | In distribution | |
| GSST3510M | In distribution | |
| TS17PA455RWH | In distribution | |
| GSTA4761NWH | In distribution | |
| GSAA6040AWH | In distribution | |
| USPTA4060R | In distribution | |
| GSMABSM | In distribution | |
| TSMTBS | In distribution | |
| GSAA6020AWH | In distribution | |
| TS10PA455MWH | In distribution | |
| GSAA4540BWH | In distribution | |
| GSTA4642WH | In distribution | |
| GSTAS4671NWH | In distribution | |
| MTR200TH | In distribution | |
| GSAA5020BWH | In distribution | |
| GSTA4762WH | In distribution | |
| GSTA5770NWH | In distribution | |
| GSTA7450NWH | In distribution | |
| GSST3540M | In distribution | |
| USPTA5020W | In distribution | |
| GSTA7420WH | In distribution | |
| GSAA4520AWH | In distribution | |
| GS30MAM4850WH | In distribution | |
| GSTA4662WH | In distribution | |
| GSTA4652WH | In distribution | |
| GSTA6470NWH | In distribution | |
| GSTA4771NWH | In distribution | |
| GSTA4761NWH | In distribution | |
| GSAA4520AWH | In distribution | |
| SSPTA4840R | In distribution | |
| TSPTA4020R | In distribution | |
| GSTA6670WH | In distribution | |
| PTCEM06S | In distribution | |
| TS17PA455RWH | In distribution | |
| GSTA4612WH | In distribution | |
| GSAA6020BWH | In distribution | |
| USPTA3530M | In distribution | |
| PTCMCB | In distribution | |
| GSTA4762NWH | In distribution | |
| GSTA5760WH | In distribution | |
| GSTA6460WH | In distribution | |
| GSTA6770NWH | In distribution | |
| GSAA4020MBWH | In distribution | |
| TSMTB0410GTH | In distribution | |
| TSPTA4020R | In distribution | |
| GS17MAM4830WH | In distribution | |
| GSTA4642WH | In distribution | |
| GSTA7670NWH | In distribution | |
| GSAA4520MAWH | In distribution | |
| GSTA4771NWH | In distribution | |
| GSAA4540AWH | In distribution | |
| PTCM06S | In distribution | |
| TSPTA3530M | In distribution | |
| RCS02 | In distribution | |
| GSTA7430WH | In distribution | |
| GSTA4652WH | In distribution | |
| USPTA4070R | In distribution | |
| GSTA5470NWH | In distribution | |
| GSTA6660WH | In distribution | |
| GSST3550R | In distribution | |
| GSTA4771WH | In distribution | |
| GSAC4080TWH | In distribution | |
| GSTA6760WH | In distribution | |
| MTR100TH | In distribution | |
| GSST3530M | In distribution | |
| GSAA4540MAWH | In distribution | |
| GS17MAS4840WH | In distribution | |
| GSTA4672NWH | In distribution | |
| GSTA4661WH | In distribution | |
| USPTA4050R | In distribution | |
| PTCM22S | In distribution | |
| GSTAS4761NWH | In distribution | |
| GSAA4020MAWH | In distribution | |
| GSTAS4761NWH | In distribution | |
| TSPTA4070R | In distribution | |
| GSST3520M | In distribution | |
| GSAA5020NWH | In distribution | |
| GSTA7470WH | In distribution | |
| USPTA3520M | In distribution | |
| PTAAH450P | In distribution | |
| TSPTA4030R | In distribution | |
| TSMSH | In distribution | |
| GSTA5760NWH | In distribution | |
| GSAA4040MNWH | In distribution | |
| USPTA5030W | In distribution | |
| GS17MAM4840WH | In distribution | |
| USPTA5040W | In distribution | |
| GSTAS4771NWH | In distribution | |
| GSTA4752WH | In distribution | |
| PTCMK | In distribution | |
| GSTA4661NWH | In distribution | |
| TS30PA455RWH | In distribution | |
| GSAA4540AWH | In distribution | |
| GSAA4520NWH | In distribution | |
| GSTA5670WH | In distribution | |
| GSTA4732WH | In distribution | |
| USPTA4030R | In distribution | |
| GSTA4752WH | In distribution | |
| MER500TH | In distribution | |
| USPTA5070W | In distribution | |
| GSAA4540MBWH | In distribution | |
| TSMTB0405GTH | In distribution | |
| GSAA4020MNWH | In distribution | |
| GSTTA4010NTH | In distribution | |
| GSTA7410NWH | In distribution | |
| GSTA7460WH | In distribution | |
| GSAA4540MAWH | In distribution | |
| TS30PA455RWH | In distribution | |
| GSAA4040MAWH | In distribution | |
| GSTA4742WH | In distribution | |
| GSAA4540BWH | In distribution | |
| MTW200TH | In distribution | |
| GSTAS4771WH | In distribution | |
| GSTA4742NWH | In distribution | |
| GSTA4661NWH | In distribution | |
| GSAA5020BWH | In distribution | |
| GSST3540M | In distribution | |
| GSTA4772NWH | In distribution | |
| GSTTA4010TH | In distribution | |
| TS17PA454RWH | In distribution | |
| GSAA5020NWH | In distribution | |
| GS17MAS4830WH | In distribution | |
| TSMTB0605GTH | In distribution | |
| GSST3510R | In distribution | |
| USPTA5050W | In distribution | |
| TSPTA4010R | In distribution | |
| GSTA7430WH | In distribution | |
| GS30MAS4850WH | In distribution | |
| GSTA6470NWH | In distribution | |
| TSPTA4040R | In distribution | |
| TSPTA4030R | In distribution | |
| TS10PA454RWH | In distribution | |
| PTCM12S | In distribution | |
| USPTA3540M | In distribution | |
| GSST3510R | In distribution | |
| TSPTA3550M | In distribution | |
| GSTA6670NWH | In distribution | |
| GSTA7450WH | In distribution | |
| USPTA3510M | In distribution | |
| PTCM06S | In distribution | |
| GSAA6040NWH | In distribution | |
| GSAA6040AWH | In distribution | |
| GSTA7460WH | In distribution | |
| GSAA6040BWH | In distribution | |
| GSTA4762WH | In distribution | |
| GSTTA4010TH | In distribution | |
| PTCM12S | In distribution | |
| GSAA4040MBWH | In distribution | |
| USPTA4020R | In distribution | |
| TSMN500TH | In distribution | |
| TS30PA454RWH | In distribution | |
| PTCM04S | In distribution | |
| GSTA4632NWH | In distribution | |
| GSTTA4030TH | In distribution | |
| GS17MAS4820WH | In distribution | |
| GSTA4622WH | In distribution | |
| GSTA4732NWH | In distribution | |
| GSTAS4661WH | In distribution | |
| GSAA4020MNWH | In distribution | |
| GSAA4040MBWH | In distribution | |
| GSTA4761WH | In distribution | |
| GSTA7460NWH | In distribution | |
| SSPTA4830R | In distribution | |
| PTCEM12S | In distribution | |
| GSTA7420WH | In distribution | |
| TSMC500TH | In distribution | |
| GSTA6660NWH | In distribution | |
| GSTA5660WH | In distribution | |
| GSFSM | In distribution | |
| GSST3550M | In distribution | |
| GS17MAS4850 | In distribution | |
| GSTAS4771NWH | In distribution | |
| GSTA6660NWH | In distribution | |
| PTCMC | In distribution | |
| TSPTA4050R | In distribution | |
| GSST3520R | In distribution | |
| TSPTA3540M | In distribution | |
| GSTA7470NWH | In distribution | |
| GSTTA4530NTH | In distribution | |
| PTCEM12S | In distribution | |
| GSST3510M | In distribution | |
| USPTA3550M | In distribution | |
| TSMTB0410GTH | In distribution | |
| GSTA5460WH | In distribution | |
| TSMN500NTH | In distribution | |
| GSTA7660NWH | In distribution | |
| GSAA6040NWH | In distribution | |
| GSST3550M | In distribution | |
| TS17PA455MWH | In distribution | |
| GSAA4520MBWH | In distribution | |
| USPTA3570M | In distribution | |
| GSAA4020MBWH | In distribution | |
| USPTA5060W | In distribution | |
| GSTA6770WH | In distribution | |
| GSTA7470NWH | In distribution |
Showing 250 of 300 catalogue numbers.
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.