SuperLine
22 catalogue numbers from FX7012SWC, listed by Dentium USA, United States, under Implant, Endosseous, Root-Form. 7 manufacturers in China are registered for this product code.
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 | Dentium USA, United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Manufacturer |
| 510(k) | K160965 |
| Record published | 2015-10-29 |
| Record revised | 2025-01-03 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Stored and transported in a dry condition in the original package at room temperature and kept away from sunlight. |
| Sizes | Length 8 to 14 mm; outer diameter 3.6 to 7 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FX7012SWC | Length 12 mm | In distribution |
| FX3612SWC | Length 12 mm | In distribution |
| FX7010SWC | Length 10 mm | In distribution |
| FX7008SWC | Length 8 mm | In distribution |
| FX3614SWC | Outer Diameter 3.6 mm | In distribution |
| FX4014SWC | Length 14 mm | In distribution |
| FX5010SWC | Outer Diameter 5 mm | In distribution |
| FX6008SWC | Outer Diameter 6 mm | In distribution |
| FX4012SWC | Length 12 mm | In distribution |
| FX6010SWC | Length 10 mm | In distribution |
| FX5012SWC | Outer Diameter 5 mm | In distribution |
| FX3608SWC | Outer Diameter 3.6 mm | In distribution |
| FX4510SWC | Outer Diameter 4.5 mm | In distribution |
| FX5014SWC | Length 14 mm | In distribution |
| FX4514SWC | Length 14 mm | In distribution |
| FX4508SWC | Length 8 mm | In distribution |
| FX4512SWC | Length 12 mm | In distribution |
| FX4010SWC | Length 10 mm | In distribution |
| FX3610SWC | Length 10 mm | In distribution |
| FX5008SWC | Outer Diameter 5 mm | In distribution |
| FX6012SWC | Outer Diameter 6 mm | In distribution |
| FX4008SWC | Outer Diameter 4 mm | In distribution |
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
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-06-29 | Not classified | Other | Lack of validation for sterilization cycle: This recall was initiated because the validation of the sterilization process for these devices has not been completed. As a result, Biomedicare cannot assure the sterility of fixtures distribute | 8,844 units | 2012-07-25 |
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.