Xive®
XiVE® TG Lab Set Implant-/Soldering Analog Bridge
7manufacturers in China registered for this device type
175catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (3), Sichuan (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Basic (Chengdu) Medical Device Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 1 |
| Dongguan Xinlonghong Hardware Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| BIO Concept Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Dentsply Implants Manufacturing GmbH, Germany |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2019-03-04 |
| Record revised | 2020-12-01 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Storage, in the original packaging, at room temperature in a dry place away from sunlight. |
| Distribution end date | 2025-10-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32261852 | In distribution | |
| 32254242 | In distribution | |
| 32254500 | In distribution | |
| 32261833 | In distribution | |
| 32261962 | In distribution | |
| 32261965 | In distribution | |
| 32261835 | In distribution | |
| 32261963 | In distribution | |
| 32261922 | In distribution | |
| 32261961 | In distribution | |
| 32261932 | In distribution | |
| 32261952 | In distribution | |
| 32261842 | In distribution | |
| 32261933 | In distribution | |
| 32261832 | In distribution | |
| 32261923 | In distribution | |
| 32261843 | In distribution | |
| 32254520 | In distribution | |
| 32261941 | In distribution | |
| 32261951 | In distribution | |
| 32261945 | In distribution | |
| 32261921 | In distribution | |
| 32261855 | In distribution | |
| 32254245 | In distribution | |
| 32261953 | In distribution | |
| 32261853 | In distribution | |
| 32254200 | In distribution | |
| 32261955 | In distribution | |
| 32254300 | In distribution | |
| 32261942 | In distribution | |
| 32261931 | In distribution | |
| 32261925 | In distribution | |
| 32261935 | In distribution | |
| 32261845 | In distribution | |
| 32261943 | In distribution | |
| 32261952 | Withdrawn | |
| 32259300 | Withdrawn | |
| 32259800 | Withdrawn | |
| 32262433 | Withdrawn | |
| 32262463 | Withdrawn | |
| 32254300 | Withdrawn | |
| 32261843 | Withdrawn | |
| 32252453 | Withdrawn | |
| 32252442 | Withdrawn | |
| 32261921 | Withdrawn | |
| 32261942 | Withdrawn | |
| 32262461 | Withdrawn | |
| 32262463 | Withdrawn | |
| 32254106 | Withdrawn | |
| 32259700 | Withdrawn | |
| 32262441 | Withdrawn | |
| 32262422 | Withdrawn | |
| 32262460 | Withdrawn | |
| 32254200 | Withdrawn | |
| 32252443 | Withdrawn | |
| 32261951 | Withdrawn | |
| 32262448 | Withdrawn | |
| 32252445 | Withdrawn | |
| 32262465 | Withdrawn | |
| 32252431 | Withdrawn | |
| 32254240 | Withdrawn | |
| 32261965 | Withdrawn | |
| 32262461 | Withdrawn | |
| 32262465 | Withdrawn | |
| 32261932 | Withdrawn | |
| 32261845 | Withdrawn | |
| 32262458 | Withdrawn | |
| 32252453 | Withdrawn | |
| 32252433 | Withdrawn | |
| 32261941 | Withdrawn | |
| 32254241 | Withdrawn | |
| 32254240 | Withdrawn | |
| 32254510 | Withdrawn | |
| 32261853 | Withdrawn | |
| 32262462 | Withdrawn | |
| 32252451 | Withdrawn | |
| 32261833 | Withdrawn | |
| 32254520 | Withdrawn | |
| 32262451 | Withdrawn | |
| 32261963 | Withdrawn | |
| 32262423 | Withdrawn | |
| 32254105 | Withdrawn | |
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| 32261922 | Withdrawn | |
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| 32252440 | Withdrawn | |
| 32262412 | Withdrawn | |
| 32261961 | Withdrawn | |
| 32262453 | Withdrawn | |
| 32254246 | Withdrawn | |
| 32261955 | Withdrawn | |
| 32261953 | Withdrawn | |
| 32262445 | Withdrawn | |
| 32254105 | Withdrawn | |
| 32254242 | Withdrawn | |
| 32262440 | Withdrawn | |
| 32254246 | Withdrawn | |
| 32262435 | Withdrawn | |
| 32259900 | Withdrawn | |
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| 32254245 | Withdrawn | |
| 32252435 | Withdrawn | |
| 32262415 | Withdrawn | |
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| 32259305 | Withdrawn | |
| 32262413 | Withdrawn | |
| 32254241 | Withdrawn | |
| 32252442 | Withdrawn | |
| 32262458 | Withdrawn | |
| 32254106 | Withdrawn | |
| 32262435 | Withdrawn | |
| 32262455 | Withdrawn | |
| 32254500 | Withdrawn | |
| 32252441 | Withdrawn | |
| 32262452 | Withdrawn | |
| 32261945 | Withdrawn | |
| 32252450 | Withdrawn | |
| 32261931 | Withdrawn | |
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| 32262451 | Withdrawn | |
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| 32259600 | Withdrawn | |
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| 32261832 | Withdrawn | |
| 32262413 | Withdrawn | |
| 32261943 | Withdrawn | |
| 32252455 | Withdrawn | |
| 32262438 | Withdrawn | |
| 32252450 | Withdrawn | |
| 32252432 | Withdrawn | |
| 32262440 | Withdrawn | |
| 32261935 | Withdrawn | |
| 32262462 | Withdrawn | |
| 32262445 | Withdrawn | |
| 32252440 | Withdrawn | |
| 32252455 | Withdrawn | |
| 32261842 | Withdrawn | |
| 32252445 | Withdrawn | |
| 32261962 | Withdrawn | |
| 32262438 | Withdrawn | |
| 32262433 | Withdrawn | |
| 32251400 | Withdrawn | |
| 32262443 | Withdrawn | |
| 32262448 | Withdrawn | |
| 32262460 | Withdrawn | |
| 32252452 | Withdrawn | |
| 32261933 | Withdrawn | |
| 32261835 | Withdrawn | |
| 32262450 | Withdrawn | |
| 32262442 | Withdrawn | |
| 32252433 | Withdrawn | |
| 32261923 | Withdrawn | |
| 32262432 | Withdrawn | |
| 32262455 | Withdrawn | |
| 32251400 | Withdrawn | |
| 32262415 | Withdrawn | |
| 32262431 | Withdrawn | |
| 32261852 | Withdrawn | |
| 32269020 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 920 |
| Osstem Implant System | Osstem Implant Co., Ltd. | 788 |
| Magicore | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 744 |
| Implant, Endosseous, Root-Form | Southern Implants (PTY) Ltd | 608 |
| ITL Dental | Emery Enterprises Inc. | 603 |
| Magicore S | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 560 |
| Friadent® | Dentsply Implants Manufacturing GmbH | 525 |
| Sphero Block Normo | Rhein 83 SRL | 489 |
| Neobiotech Implant System | Neobiotech Co., Ltd. | 483 |
| KJ Mini Implant System | Kjmeditech.co., Ltd. | 448 |
| Ritter Dental Implant System | Ritter Implants GmbH & Co. KG | 418 |
| Leone SPA | Leone SPA | 404 |
Showing 12 of 2,762. All products under Implant, Endosseous, Root-Form
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130999 | 2013-10-25 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P800035 | 2001-10-04 | PERI-OSS | Curasan AG |
| P860012 | 1988-10-28 | ALVEOFORM TM BIOGRAFT | Collagen Corp. |
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.