KJ Mini Implant System
KJ Mini Implant System/OneBody Implant
7manufacturers in China registered for this device type
448catalogue 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 | Kjmeditech.co., Ltd. |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| 510(k) | K151970 |
| Record published | 2019-11-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MIPSW20112-16 | In distribution | |
| MIBR2010-18 | In distribution | |
| OBL5012 | In distribution | |
| MIPR5016-25 | In distribution | |
| MIPS2516-18 | In distribution | |
| MIPR5012-25D | In distribution | |
| MIPR5011-25 | In distribution | |
| OBL4508D | In distribution | |
| MIPR3510-18 | In distribution | |
| MIPS2515-18 | In distribution | |
| OBL5012D | In distribution | |
| OBM5013 | In distribution | |
| MIPR4512-25 | In distribution | |
| MIPSW20102-16 | In distribution | |
| MIBS4013-25 | In distribution | |
| OBL4014D | In distribution | |
| MIPS5012-25 | In distribution | |
| MIBS3014-18 | In distribution | |
| MIBR4010-25D | In distribution | |
| OBM4516 | In distribution | |
| MIPR4514-25D | In distribution | |
| MIPR2511-18 | In distribution | |
| MIPR3010-18 | In distribution | |
| MIPS4516-25 | In distribution | |
| MIBS4016-25 | In distribution | |
| MIBS4515-25 | In distribution | |
| OBL4016D | In distribution | |
| MIPS2010-18 | In distribution | |
| OBL3014 | In distribution | |
| MIPS3510-18 | In distribution | |
| MIBR5010-25D | In distribution | |
| MIBR2012-18 | In distribution | |
| OBM4514 | In distribution | |
| MIBR2513-18 | In distribution | |
| OBL3015 | In distribution | |
| MIPR4514-25 | In distribution | |
| MIPR4513-25 | In distribution | |
| MIPS3514-18 | In distribution | |
| OBL4015D | In distribution | |
| MIPS2008-18 | In distribution | |
| MIPS4514-25 | In distribution | |
| MIBS2515-18 | In distribution | |
| OBM3010 | In distribution | |
| MIPR2015-18 | In distribution | |
| MIPSW20161-16 | In distribution | |
| MIPR3513-25 | In distribution | |
| MIPS4015-25 | In distribution | |
| MIBR2011-18 | In distribution | |
| MIPS2513-18 | In distribution | |
| MIPS4013-25 | In distribution | |
| OBM3515 | In distribution | |
| MIBR3516-25 | In distribution | |
| OBL4008 | In distribution | |
| MIPR3514-25 | In distribution | |
| OBM4513 | In distribution | |
| OBL4510D | In distribution | |
| OBL4508 | In distribution | |
| MIPSW20142-16 | In distribution | |
| MIBR5008-25D | In distribution | |
| OBL3510 | In distribution | |
| OBL2508 | In distribution | |
| OBL5013 | In distribution | |
| MIPSW20152-16 | In distribution | |
| MIPR5012-25 | In distribution | |
| MIPS3513-25 | In distribution | |
| MIPS3512-18 | In distribution | |
| MIBR4511-25D | In distribution | |
| MIPR2016-18 | In distribution | |
| MIPS4510-25 | In distribution | |
| MIBS2508-18 | In distribution | |
| OBL3010 | In distribution | |
| MIPSW20151-16 | In distribution | |
| MIBS3010-18 | In distribution | |
| MIPSW20141-16 | In distribution | |
| OBM3011 | In distribution | |
| OBM3012 | In distribution | |
| MIBR3012-18 | In distribution | |
| MIPS3010-18 | In distribution | |
| MIBR3508-25 | In distribution | |
| MIBS3510-25 | In distribution | |
| OBL4012D | In distribution | |
| OBL4511D | In distribution | |
| MIPR5011-25D | In distribution | |
| MIPR3510-25 | In distribution | |
| MIBR5010-25 | In distribution | |
| MIPR4012-25D | In distribution | |
| MIBS2016-18 | In distribution | |
| OBM4008 | In distribution | |
| MIBR5015-25D | In distribution | |
| OBM3510 | In distribution | |
| OBL3511 | In distribution | |
| MIPSW20162-16 | In distribution | |
| OBL5014 | In distribution | |
| MIPR4015-25D | In distribution | |
| OBL4012 | In distribution | |
| MIBS3511-25 | In distribution | |
| MIPS2514-18 | In distribution | |
| MIBR5015-25 | In distribution | |
| MIBR3016-18 | In distribution | |
| MIPS5011-25 | In distribution | |
| MIBR4512-25D | In distribution | |
| MIBR2512-18 | In distribution | |
| OBL5010D | In distribution | |
| MIBR3513-25 | In distribution | |
| MIBR5014-25D | In distribution | |
| OBL4013 | In distribution | |
| MIPR4516-25D | In distribution | |
| MIBR2508-18 | In distribution | |
| MIBS2510-18 | In distribution | |
| MIPR2014-18 | In distribution | |
| OBL4516 | In distribution | |
| OBM2514 | In distribution | |
| MIPS3016-18 | In distribution | |
| MIBR4013-25D | In distribution | |
| MIPS3508-18 | In distribution | |
| MIPS2508-18 | In distribution | |
| MIBS2014-18 | In distribution | |
| MIBS4010-25 | In distribution | |
| MIPR4510-25 | In distribution | |
| MIPS3511-18 | In distribution | |
| MIPS3015-18 | In distribution | |
| OBM3013 | In distribution | |
| MIPS3516-18 | In distribution | |
| MIBS4510-25 | In distribution | |
| MIBR3514-18 | In distribution | |
| MIPR4511-25 | In distribution | |
| MIPR3516-25 | In distribution | |
| MIPR4008-25D | In distribution | |
| MIPR4012-25 | In distribution | |
| MIBR3010-18 | In distribution | |
| MIPSW20131-16 | In distribution | |
| MIPR2008-18 | In distribution | |
| OBL4514 | In distribution | |
| MIBR5008-25 | In distribution | |
| MIBR4513-25 | In distribution | |
| MIPS2511-18 | In distribution | |
| OBL4014 | In distribution | |
| MIBR3510-25 | In distribution | |
| MIPS3511-25 | In distribution | |
| MIBS2011-18 | In distribution | |
| OBM3514 | In distribution | |
| OBM4515 | In distribution | |
| OBM4512 | In distribution | |
| MIPS3515-25 | In distribution | |
| MIPR4508-25D | In distribution | |
| MIPSW20122-16 | In distribution | |
| MIBR3511-25 | In distribution | |
| MIPR5010-25D | In distribution | |
| MIBS4015-25 | In distribution | |
| MIPR3515-18 | In distribution | |
| MIPR4510-25D | In distribution | |
| MIPSW20111-16 | In distribution | |
| OBL2516 | In distribution | |
| MIBR5011-25D | In distribution | |
| MIBR2516-18 | In distribution | |
| MIPS2510-18 | In distribution | |
| MIPR4513-25D | In distribution | |
| OBM3014 | In distribution | |
| MIPR4515-25 | In distribution | |
| MIBS2513-18 | In distribution | |
| MIPR4011-25 | In distribution | |
| MIBR3014-18 | In distribution | |
| MIBR2511-18 | In distribution | |
| MIBR4011-25D | In distribution | |
| MIPS4010-25 | In distribution | |
| OBM5015 | In distribution | |
| MIPR5016-25D | In distribution | |
| MIBR3011-18 | In distribution | |
| MIBS3012-18 | In distribution | |
| MIBR4508-25 | In distribution | |
| MIBS3512-18 | In distribution | |
| MIPS4511-25 | In distribution | |
| MIPR2515-18 | In distribution | |
| MIBS2514-18 | In distribution | |
| MIBS5016-25 | In distribution | |
| OBL4008D | In distribution | |
| MIPR3008-18 | In distribution | |
| OBL4515 | In distribution | |
| MIBR5012-25D | In distribution | |
| MIPR2011-18 | In distribution | |
| MIBR4016-25 | In distribution | |
| MIBR5011-25 | In distribution | |
| OBL5011D | In distribution | |
| MIBS3513-25 | In distribution | |
| MIBR4514-25D | In distribution | |
| MIPR3514-18 | In distribution | |
| MIPS2015-18 | In distribution | |
| OBL2513 | In distribution | |
| OBL4011 | In distribution | |
| MIPR5008-25 | In distribution | |
| OBL5014D | In distribution | |
| MIPS2013-18 | In distribution | |
| MIBR3515-18 | In distribution | |
| OBM4015 | In distribution | |
| MIBS3514-25 | In distribution | |
| OBL5010 | In distribution | |
| MIPR2516-18 | In distribution | |
| MIPS4512-25 | In distribution | |
| MIBR2515-18 | In distribution | |
| MIBR3008-18 | In distribution | |
| OBL3513 | In distribution | |
| OBM3511 | In distribution | |
| MIPR3013-18 | In distribution | |
| MIPR3016-18 | In distribution | |
| MIPR4011-25D | In distribution | |
| MIPSW20113-16 | In distribution | |
| MIPR3014-18 | In distribution | |
| MIPS2014-18 | In distribution | |
| MIPS5016-25 | In distribution | |
| MIBR2510-18 | In distribution | |
| MIBS4514-25 | In distribution | |
| MIBR4012-25D | In distribution | |
| MIPS3513-18 | In distribution | |
| OBL5008 | In distribution | |
| MIPS3012-18 | In distribution | |
| MIPR4010-25 | In distribution | |
| MIPS3011-18 | In distribution | |
| OBM5010 | In distribution | |
| OBM3512 | In distribution | |
| MIPS2011-18 | In distribution | |
| MIBS4516-25 | In distribution | |
| MIPS5008-25 | In distribution | |
| OBL4010D | In distribution | |
| MIBS3515-18 | In distribution | |
| MIBS5013-25 | In distribution | |
| OBL4511 | In distribution | |
| MIPS2012-18 | In distribution | |
| MIPR2010-18 | In distribution | |
| MIBS5008-25 | In distribution | |
| MIPSW20123-16 | In distribution | |
| MIBR4510-25D | In distribution | |
| OBL4013D | In distribution | |
| OBL4512D | In distribution | |
| MIPR2512-18 | In distribution | |
| MIBR5013-25D | In distribution | |
| OBL4015 | In distribution | |
| MIBS5014-25 | In distribution | |
| MIBR3516-18 | In distribution | |
| MIBR4510-25 | In distribution | |
| MIPR4516-25 | In distribution | |
| MIBR2015-18 | In distribution | |
| MIPS5010-25 | In distribution | |
| MIPSW20103-16 | In distribution | |
| MIPSW20153-16 | In distribution | |
| MIBR4011-25 | In distribution | |
| MIPS3512-25 | In distribution | |
| MIPR4016-25D | In distribution | |
| MIBR4515-25D | In distribution | |
| MIBS2015-18 | In distribution | |
| OBM4011 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| Ritter Dental Implant System | Ritter Implants GmbH & Co. KG | 418 |
| Leone SPA | Leone SPA | 404 |
| Ankylos® | Dentsply Implants Manufacturing GmbH | 391 |
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.