SuperLine II
32 catalogue numbers from FXS4514C, listed by Dentium USA, United States, under Implant, Endosseous, Root-Form. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
32catalogue numbers in this listing
1recall
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 | 2020-01-27 |
| Record revised | 2024-12-30 (version 4) |
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 | Outer diameter 3.6 to 7 mm; length 7 to 14 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FXS4514C | Outer Diameter 4.5 mm | In distribution |
| FXS4510C | Length 10 mm | In distribution |
| FXS5010C | Length 10 mm | In distribution |
| FXS6008C | Outer Diameter 6 mm | In distribution |
| FXS3607C | Outer Diameter 3.6 mm | In distribution |
| FXS4007BC | Outer Diameter 3.6 mm | In distribution |
| FXS7010C | Length 10 mm | In distribution |
| FXS5007BC | Outer Diameter 5.0 mm | In distribution |
| FXS4008C | Length 8 mm | In distribution |
| FXS4014C | Outer Diameter 4 mm | In distribution |
| FXS4512C | Outer Diameter 4.5 mm | In distribution |
| FXS5007C | Outer Diameter 5.0 mm | In distribution |
| FXS3608C | Length 8 mm | In distribution |
| FXS3610C | Length 10 mm | In distribution |
| FXS3607BC | Outer Diameter 3.6 mm | In distribution |
| FXS7008C | Length 8 mm | In distribution |
| FXS6010C | Length 10 mm | In distribution |
| FXS4007C | Outer Diameter 4 mm | In distribution |
| FXS4507C | Outer Diameter 4.5 mm | In distribution |
| FXS5014C | Length 14 mm | In distribution |
| FXS5008C | Length 8 mm | In distribution |
| FXS4508C | Length 8 mm | In distribution |
| FXS3614C | Length 14 mm | In distribution |
| FXS6007C | Outer Diameter 6 mm | In distribution |
| FXS4010C | Length 10 mm | In distribution |
| FXS3612C | Length 12 mm | In distribution |
| FXS7007C | Outer Diameter 7 mm | In distribution |
| FXS7012C | Length 12 mm | In distribution |
| FXS5012C | Length 12 mm | In distribution |
| FXS4012C | Outer Diameter 4 mm | In distribution |
| FXS6012C | Length 12 mm | In distribution |
| FXS4507BC | Outer Diameter 4.5 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.