Straumann® PUREloc Abutments
Straumann PUREloc is a ceramic abutment for retaining full or partial dentures on compatible PURE Ceramic implants. The non-engaging abutment connects to the implant through a basal screw.…
Straumann PUREloc is a ceramic abutment for retaining full or partial dentures on compatible PURE Ceramic implants. The non-engaging abutment connects to the implant through a basal screw.
The abutment body is yttrium-stabilized zirconia, while the basal screw is commercially pure Grade 4 titanium. Six abutment heights, from 1 to 6 mm, accommodate the restorative setup.
Listed Item
CI RD Straumann® PUREloc, straight 0°, H 4mm, ZrO2/Ti
Retentive System
PUREloc belongs to the Straumann retentive system for implant-supported overdentures and partial dentures in the upper or lower jaw. The ceramic abutment is specified exclusively for the matching PURE Ceramic implant connection.
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 | Institut Straumann AG, Switzerland |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K192029 |
| Record published | 2020-01-25 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| Sizes | Height 1 to 6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Edentulous Abutments | Height 4 mm | In distribution |
| Edentulous Abutments | Height 3 mm | In distribution |
| Edentulous Abutments | Height 5 mm | In distribution |
| Edentulous Abutments | Height 1 mm | In distribution |
| Edentulous Abutments | Height 6 mm | In distribution |
| Edentulous Abutments | Height 2 mm | 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 |
|---|---|
| K260460 | 2026-05-07 |
| K253315 | 2026-01-22 |
| K243278 | 2025-02-21 |
| K243478 | 2025-02-19 |
| K222836 | 2023-05-15 |
| K220878 | 2022-06-16 |
| K220751 | 2022-06-02 |
| K213063 | 2022-04-08 |
| K203750 | 2021-10-09 |
| K203456 | 2021-06-23 |
| K201681 | 2021-03-18 |
| K192742 | 2021-02-12 |
| K203355 | 2021-02-12 |
| K193046 | 2020-08-13 |
| K192893 | 2020-01-03 |
| K192029 | 2019-10-28 |
| K190654 | 2019-06-28 |
| K190097 | 2019-06-26 |
| K190082 | 2019-04-17 |
| K190040 | 2019-04-08 |
| K173945 | 2018-10-05 |
| K173968 | 2018-07-17 |
| K173379 | 2018-03-30 |
| K171649 | 2018-02-22 |
| K172798 | 2018-01-03 |
| K171773 | 2017-12-01 |
| K162848 | 2017-09-22 |
| K170354 | 2017-06-07 |
| K170356 | 2017-06-07 |
| K161677 | 2016-10-07 |
| K120822 | 2012-12-21 |
| K101465 | 2010-12-13 |
| K091701 | 2009-12-22 |
| K093113 | 2009-12-18 |
| K082545 | 2008-10-17 |
| K082764 | 2008-10-01 |
| K081186 | 2008-05-23 |
| K081005 | 2008-05-02 |
| K072679 | 2007-10-12 |
| K071357 | 2007-09-26 |
| K072497 | 2007-09-26 |
| K070549 | 2007-08-31 |
| K072071 | 2007-08-15 |
| K070744 | 2007-06-29 |
| K051717 | 2005-07-07 |
| K041295 | 2004-05-24 |
| K040539 | 2004-03-18 |
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.