Strong SW
Implant Strong SW EXT HEX Ø4,5X11,5MM
7manufacturers in China registered for this device type
85catalogue numbers in this listing
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 | SIN Sistema DE Implante Nacional S.A |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| 510(k) | K170398 |
| Record published | 2022-04-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SCWE 4515 | In distribution | |
| SCWE 4511 | In distribution | |
| CMSW 4515 | In distribution | |
| CMSW 4510 | In distribution | |
| SWCM 4511 | In distribution | |
| SWCM 5013 | In distribution | |
| SW 3885 | In distribution | |
| CMSW 3515 | In distribution | |
| SCW 3785 | In distribution | |
| SW 4515 | In distribution | |
| CMSW 5013 | In distribution | |
| SWCM 4510 | In distribution | |
| SW 5015 | In distribution | |
| SCW 5013 | In distribution | |
| SCWE 4585 | In distribution | |
| SW 3811 | In distribution | |
| SWHE 3513 | In distribution | |
| SWCM 5011 | In distribution | |
| SWCM 4513 | In distribution | |
| CMSW 3511 | In distribution | |
| SWCM 4585 | In distribution | |
| SW 3813 | In distribution | |
| CMSW 3585 | In distribution | |
| SCW 3713 | In distribution | |
| CMSW 3810 | In distribution | |
| SCWE 4513 | In distribution | |
| CMSW 3813 | In distribution | |
| SCW 5011 | In distribution | |
| SWHE 3713 | In distribution | |
| CMSW 3510 | In distribution | |
| SWCM 3815 | In distribution | |
| CMSW 3815 | In distribution | |
| SCW 3711 | In distribution | |
| SCW 5015 | In distribution | |
| SWCM 5015 | In distribution | |
| SCW 3710 | In distribution | |
| SWCM 3585 | In distribution | |
| CMSW 5010 | In distribution | |
| SW 4513 | In distribution | |
| SW 5010 | In distribution | |
| SCW 3707 | In distribution | |
| SWCM 3510 | In distribution | |
| SW 3815 | In distribution | |
| SWHE 3585 | In distribution | |
| SWHE 3711 | In distribution | |
| CMSW 4585 | In distribution | |
| SCW 3718 | In distribution | |
| CMSW 4511 | In distribution | |
| SWHE 3511 | In distribution | |
| CMSW 3885 | In distribution | |
| SWCM 3513 | In distribution | |
| SWCM 5085 | In distribution | |
| CMSW 5011 | In distribution | |
| SW 4585 | In distribution | |
| SWCM 3813 | In distribution | |
| CMSW 5085 | In distribution | |
| CMSW 3513 | In distribution | |
| SWHE 3707 | In distribution | |
| SWCM 5010 | In distribution | |
| SCWE 4510 | In distribution | |
| SWCM 3811 | In distribution | |
| SWCM 4515 | In distribution | |
| SW 4511 | In distribution | |
| SW 4510 | In distribution | |
| SCW 5010 | In distribution | |
| CMSW 5015 | In distribution | |
| CMSW 3811 | In distribution | |
| SW 3810 | In distribution | |
| SWHE 3715 | In distribution | |
| SWHE 3507 | In distribution | |
| SCW 5007 | In distribution | |
| SCW 3715 | In distribution | |
| SWCM 3885 | In distribution | |
| SCW 5085 | In distribution | |
| SWHE 3510 | In distribution | |
| SW 5011 | In distribution | |
| SW 5013 | In distribution | |
| SW 5085 | In distribution | |
| SWCM 3511 | In distribution | |
| CMSW 4513 | In distribution | |
| SWCM 3810 | In distribution | |
| SWHE 3785 | In distribution | |
| SWHE 3515 | In distribution | |
| SWHE 3710 | In distribution | |
| SWCM 3515 | 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
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.