SM Internal/External Implant Systems
67 catalogue numbers from IPN 40510, listed by DIO Corporation, South Korea, under Accessories, Implant, Dental, Endosseous. 70 manufacturers in China are registered for this product code.
70manufacturers in China registered for this device type
67catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (28), Jiangsu (9), Zhejiang (6). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Xiamen Yizhou IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 10 |
| Amedcon Medical Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
Showing 12 of 70. All 70 manufacturers in China registered for Accessories, Implant, Dental, Endosseous
Record
| Listed by | DIO Corporation, South Korea |
|---|---|
| FDA product code | NDP |
| Device type | Accessories, Implant, Dental, Endosseous |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3980 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K070569 |
| Record published | 2022-03-01 |
| Record revised | 2022-11-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature 1 to 30 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN 40510 | Ø4.8X9.4mm | In distribution |
| IPN 40512N | Ø4.8X12.0mm | In distribution |
| PMN 35310 | Ø1.6X10.0mm | In distribution |
| PCN 40310 | Ø1.4X10.0mm | In distribution |
| RMI 48004N | Ø4.8X4.0mm | In distribution |
| IPT 50612 | Ø5.8X12.0mm | In distribution |
| ITI 48010S | Ø4.0X15.0mm | In distribution |
| RCI 48014 | Ø4.8X14.0mm | In distribution |
| IPN 3508 | Ø3.8X8.0mm | In distribution |
| IPI 48002Y | 10.0mm(Yellow) | In distribution |
| RMN 50512 | Ø5.1X12.0mm | In distribution |
| IPT 5008 | Ø5.8X8.0mm | In distribution |
| IPI 48004NEX | Ø5.2X10.2mm | In distribution |
| IPI 48002YEX | 5.7mm(Yellow) | In distribution |
| IPI 48001 | Ø5.7X8.0mm | In distribution |
| IPI 65002G | 10.0mm(Gray) | In distribution |
| IPN 4008 | Ø4.8X8.0mm | In distribution |
| IPN 40510N | Ø4.8X8.0mm | In distribution |
| RCN 50512 | Ø5.5X11.7mm | In distribution |
| IPN 50608N | Ø5.5X8.0mm | In distribution |
| PCN 50310 | Ø2.0X10.0mm | In distribution |
| ITT 50612H | Ø6.0.X9.5mm | In distribution |
| ITN 35412 | Ø4.4X11.0mm | In distribution |
| IPN 5008N | Ø5.8X8.0mm | In distribution |
| IPN 3508N | Ø3.8X8.0mm | In distribution |
| IPI 48002GEX | 5.7mm(Gray) | In distribution |
| RMN 35312 | Ø3.5X12.0mm | In distribution |
| PMN 50315 | Ø2.5X15.0mm | In distribution |
| ITN 50612S | Ø4.9X16mm | In distribution |
| IPN 5008 | Ø5.8X8.0mm | In distribution |
| ITN 40512H | Ø4.8X9.5mm | In distribution |
| PMN 35315 | Ø1.6X15.0mm | In distribution |
| IPN 40508N | Ø4.8X8.0mm | In distribution |
| IPN 40508 | Ø4.8X8.0mm | In distribution |
| ITN 35412H | Ø4.0X9.5mm | In distribution |
| IPI 65002Y | 10.0mm(Yellow) | In distribution |
| IPI 48002B | 10.0mm(Blue) | In distribution |
| IPN 40512 | Ø4.8X12.0mm | In distribution |
| PMN 40310 | Ø2.0X10.0mm | In distribution |
| RMN 40412 | Ø4.1X12.0mm | In distribution |
| ITN 40512 | Ø5.0X11.0mm | In distribution |
| POI 2610 | Ø2.5X10.0mm | In distribution |
| RMI 48005N | Ø4.8X5.5mm | In distribution |
| ITN 40512S | Ø4.0X16mm | In distribution |
| IPN 50612N | Ø5.8X12.0mm | In distribution |
| IPN 50612 | Ø5.8X12.0mm | In distribution |
| IPI 48002BEX | 5.7mm(Blue) | In distribution |
| IPN 50608 | Ø5.5X8.0mm | In distribution |
| RCN 40414 | Ø4.8X13.7mm | In distribution |
| IPI 48004N | Ø5.2X10.2mm | In distribution |
| IPT 50612N | Ø5.8X12.0mm | In distribution |
| ITN 35412S | Ø3.2X16mm | In distribution |
| ITN 50612H | Ø6.0X9.5mm | In distribution |
| IPT 5008N | Ø5.8X8.0mm | In distribution |
| IPI 48002G | 10.0mm(Gray) | In distribution |
| ITN 50612 | Ø6.0X11.0mm | In distribution |
| RBN 40412 | Ø4.1X12.0mm | In distribution |
| IPN 4008N | Ø4.8X8.0mm | In distribution |
| RMI 48007N | Ø4.8X7.0mm | In distribution |
| RCN 40412 | Ø4.8X11.9mm | In distribution |
| PMN 50310 | Ø2.5X10.0mm | In distribution |
| ITT 50612 | Ø6.0X11.0mm | In distribution |
| RMI 48001 | Ø4.8X10.0mm | In distribution |
| PMN 40315 | Ø2.0X15.0mm | In distribution |
| RMT 50512 | Ø5.0X12.0mm | In distribution |
| ITT 50612S | Ø4.9X16mm | In distribution |
| IPI 48004EX | Ø5.2X10.2mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Accessories, Implant, Dental, Endosseous | Southern Implants (PTY) Ltd | 1,379 |
| Accessories, Implant, Dental, Endosseous | Institut Straumann AG | 1,320 |
| Neobiotech Implant System | Neobiotech Co., Ltd. | 1,112 |
| Inclusive | Prismatik Dentalcraft, Inc. | 1,045 |
| Medentika | Medentika GmbH | 1,042 |
| BioHorizons | Biohorizons Implant Systems Inc. | 1,008 |
| IPD | Implant Protesis Dental 2004 SL | 998 |
| Klockner | Soadco, S.L. | 995 |
| Dynamic Abutment Solutions | Talladium España, SL | 877 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 738 |
| Nobel Biocare® | Nobel Biocare AB | 703 |
| MIS | MIS Implants Technologies Ltd. | 615 |
Showing 12 of 7,548. All products under Accessories, Implant, Dental, Endosseous
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.