Passive Abutment
Vertical Passive Abutment, Non-Engaging, for Ø4.0 Ex Hex
15manufacturers in China registered for this device type
22catalogue numbers in this listing
5510(k) clearances naming this product code
2recalls on this 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 | Southern Implants (PTY) Ltd, South Africa |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K061169 |
| Record published | 2019-01-23 |
| Record revised | 2022-11-11 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ITS-PA-NE | In distribution | |
| SB-17-TT | In distribution | |
| PA-NDC5 | In distribution | |
| PA-MC-48 | In distribution | |
| SBV-17-TT | In distribution | |
| SPV16 | In distribution | |
| ITS-PA | In distribution | |
| SB16 | In distribution | |
| ITS6-PA | In distribution | |
| PA-NDC3 | In distribution | |
| PA-EL-60 | In distribution | |
| PA-EL-43 | In distribution | |
| PA-DC3 | In distribution | |
| PA-DC4 | In distribution | |
| SP17 | In distribution | |
| SBV16 | In distribution | |
| PA-DC5 | In distribution | |
| PA-NDC4 | In distribution | |
| SP16 | In distribution | |
| ITS6-PA-NE | In distribution | |
| PA-EL-50 | In distribution | |
| PA-EL-35 | 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 |
|---|---|
| K230873 | 2023-08-01 |
| K222469 | 2023-04-17 |
| K193084 | 2020-10-27 |
| K191250 | 2019-12-05 |
| K172160 | 2018-02-09 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Southern Implants (PTY) Ltd | 510(k) number | 2013-09-13 | Class II | Labeling design | Southern Implants is recalling the Tri-Nex healing abutment because the package was incorrectly labeled and packaged as the Tri-Nex healing abutment, 05.0 mm x 5 mm height (HA-L-50-5). The package contains the Tri-Nex healing abutment 05.0 | 197 units | 2014-01-21 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-03-08 | Class II | Process control | The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13. | 49 units | 2019-09-26 |
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.