SM Internal/External Implant Systems
132 catalogue numbers from ACN 40546, listed by DIO Corporation, South Korea, under Abutment, Implant, Dental, Endosseous. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
132catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (2), Shanghai (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Exceldent Dental Technology Development Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 12 |
| DTS Digital Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 11 |
| KTJ Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shimmer Computerized Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 10 |
| Zhuhai Crystal Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 9 |
| NEW Perfect Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| CBD Dental LAB, Inc | Shenzhen | Guangdong | Manufacturer | 11 |
Showing 12 of 15. All 15 manufacturers in China registered for Abutment, Implant, Dental, Endosseous
Record
| Listed by | DIO Corporation, South Korea |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| 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 |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 1 to 30 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ACN 40546 | Ø4.8X4.0(Cuff)mm | In distribution |
| AHN 40503 | Ø5.0X3.0mm | In distribution |
| AHN 35405 | Ø4.0X5.0mm | In distribution |
| AAN 50425 | Ø6.0X4.0mm | In distribution |
| APN 40513N | Ø4.5X13.0mm | In distribution |
| HMI 48554 | Ø5.5X4.0mm | In distribution |
| CHN 4000N | Ø1.6X4.2mm | In distribution |
| AHN 35406 | Ø4.0X6.0mm | In distribution |
| HCN 50604 | Ø5.8X4.5mm | In distribution |
| AHI 48601H | Ø5.5X1.5mm | In distribution |
| AMI 48435EX | Ø4.3X5.5mm | In distribution |
| ABI 48350 | Ø3.5X0.0mm | In distribution |
| ACN 40523 | Ø4.8X2.0(Cuff)mm | In distribution |
| HMI 48555EX | Ø5.5X5.5mm | In distribution |
| AAN 35415 | Ø4.0X4.0mm | In distribution |
| AHN 40604 | Ø6.0X4.0mm | In distribution |
| AHN 40504 | Ø5.0X4.0mm | In distribution |
| AHN 35402 | Ø2.0X4.0mm | In distribution |
| AMI 48007N | Ø4.3X0.0(Cuff)mm | In distribution |
| AHN 50602 | Ø6.0X2.0mm | In distribution |
| AMI 48017N | Ø4.8X1.0(Cuff)mm | In distribution |
| AHN 40602 | Ø6.0X2.0mm | In distribution |
| CHN 3501 | Ø3.5X5.8mm | In distribution |
| AMI 48027N | Ø4.8X2.0(Cuff)mm | In distribution |
| AAN 40425 | Ø5.0X4.0mm | In distribution |
| HMI 48554EX | Ø5.5X4.0mm | In distribution |
| SHN 2011S | Ø3.1X4.0mm | In distribution |
| AHT 50602 | Ø6.0X2.0mm | In distribution |
| API 48514N | Ø5.1X10.0mm | In distribution |
| APN 40514S | Ø5.2X13.0mm | In distribution |
| AHN 40502 | Ø5.0X2.0mm | In distribution |
| AMI 48437EX | Ø4.3X7.0mm | In distribution |
| CHN 5001 | Ø5.1X5.8mm | In distribution |
| AHN 35408 | Ø4.0X8.0mm | In distribution |
| ACT 50623 | Ø5.5X2.0(Cuff)mm | In distribution |
| APN 40514N | Ø5.2X14.0mm | In distribution |
| ACI 48302 | Ø3.5X6.5mm | In distribution |
| SHN 2008S | Ø3.1X1.0mm | In distribution |
| AHN 40608 | Ø6.0X8.0mm | In distribution |
| APN 40513 | Ø4.5X13.0mm | In distribution |
| AMI 48434EX | Ø4.3X4.0mm | In distribution |
| ACT 50645 | Ø5.5X4.0(Cuff)mm | In distribution |
| HMI 48555 | Ø5.5X5.5mm | In distribution |
| AHN 35404 | Ø4.0X4.0mm | In distribution |
| ACN 40513 | Ø4.8X1.0(Cuff)mm | In distribution |
| AHN 50604 | Ø6.0X4.0mm | In distribution |
| AHN 40508 | Ø5.0X8.0mm | In distribution |
| AAN 35225 | Ø4.0X2.0mm | In distribution |
| AAT 50215 | Ø6.0X2.0mm | In distribution |
| APT 50613 | Ø5.5X13.0mm | In distribution |
| AAN 40225 | Ø5.0X2.0mm | In distribution |
| ACT 50634 | Ø5.5X3.0(Cuff)mm | In distribution |
| HCN 40504 | Ø5.0X4.5mm | In distribution |
| APN 35413 | Ø4.0X13.0mm | In distribution |
| APT 50613N | Ø5.5X13.0mm | In distribution |
| ACN 40524 | Ø4.8X2.0(Cuff)mm | In distribution |
| ABI 48354 | Ø3.5X4.0mm | In distribution |
| ACN 40535 | Ø4.8X3.0(Cuff)mm | In distribution |
| ACN 50634 | Ø5.5X3.0(Cuff)mm | In distribution |
| ABI 48352 | Ø3.5X2.0mm | In distribution |
| AHN 35403 | Ø4.0X3.0mm | In distribution |
| SHN 1404 | Ø1.4X4.3mm | In distribution |
| AAN 35425 | Ø4.0X4.0mm | In distribution |
| AHN 50603 | Ø6.0X3.0mm | In distribution |
| ACI 65302 | Ø4.3X7.0mm | In distribution |
| HMI 48557 | Ø5.5X7.0mm | In distribution |
| SSN 1403 | Ø1.4X3.0mm | In distribution |
| BC 5004 | Ø5.0X4.0mm | In distribution |
| ACN 40534 | Ø4.8X3.0(Cuff)mm | In distribution |
| SHN 2510 | Ø3.6X3.0mm | In distribution |
| AAT 50425 | Ø6.0X4.0mm | In distribution |
| AMI 48357 | Ø3.5X7.0mm | In distribution |
| AAI 35025 | Ø3.5X25.0(Cuff)mm | In distribution |
| SSN 2003 | Ø2.0X3.0mm | In distribution |
| ACT 50612 | Ø5.5X1.0(Cuff)mm | In distribution |
| AAN 40215 | Ø5.0X2.0mm | In distribution |
| AHI 48602H | Ø5.5X2.0mm | In distribution |
| AHN 40606 | Ø6.0X6.0mm | In distribution |
| AAN 50215 | Ø6.0X2.0mm | In distribution |
| ACN 40545 | Ø4.8X4.0(Cuff)mm | In distribution |
| SHN 2509 | Ø3.6X2.0mm | In distribution |
| AHN 50608 | Ø6.0X8.0mm | In distribution |
| HCN 40506 | Ø5.0X6.0mm | In distribution |
| AHI 48603H | Ø5.5X3.0mm | In distribution |
| AMI 48354 | Ø3.5X4.0mm | In distribution |
| AAT 50415 | Ø6.0X4.0mm | In distribution |
| API 48514 | Ø5.1X10.0mm | In distribution |
| SHN 2009S | Ø3.1X2.0mm | In distribution |
| SSN 1404 | Ø1.4X3.6mm | In distribution |
| SHN 2009 | Ø2.95X1.0mm | In distribution |
| HMI 48557EX | Ø5.5X7.0mm | In distribution |
| AAT 50225 | Ø6.0X4.0mm | In distribution |
| AHN 40603 | Ø6.0X3.0mm | In distribution |
| AHT 50608 | Ø6.0X8.0mm | In distribution |
| AAN 50415 | Ø6.0X4.0mm | In distribution |
| AHT 50605 | Ø6.0X5.0mm | In distribution |
| APN 50613 | Ø5.5X13.0mm | In distribution |
| AAN 40415 | Ø5.0X4.0mm | In distribution |
| APN 35413N | Ø4.0X13.0mm | In distribution |
| AHT 50603 | Ø6.0X3.0mm | In distribution |
| SHN 2508 | Ø3.6X1.0mm | In distribution |
| AAN 35215 | Ø4.0X2.0mm | In distribution |
| AHT 50606 | Ø6.0X6.0mm | In distribution |
| CHN 5000N | Ø2.5X4.2mm | In distribution |
| AHT 50604 | Ø6.0X4.0mm | In distribution |
| ACN 40512 | Ø4.8X1.0(Cuff)mm | In distribution |
| CHT 5001 | Ø5.0X5.8mm | In distribution |
| AHN 50606 | Ø6.0X6.0mm | In distribution |
| APN 40514SN | Ø5.2X13.0mm | In distribution |
| AHN 40605 | Ø6.0X5.0mm | In distribution |
| SHN 2011 | Ø2.95X3.0mm | In distribution |
| SHN 2511 | Ø3.6X4.0mm | In distribution |
| AMI 48037N | Ø4.8X3.0(Cuff)mm | In distribution |
| ACN 50612 | Ø5.5X1.0(Cuff)mm | In distribution |
| ACN 50645 | Ø5.5X4.0(Cuff)mm | In distribution |
| RT 0502 | Ø5.0X2.0mm | In distribution |
| APN 50613N | Ø5.5X13.0mm | In distribution |
| SHN 2003 | Ø2.0X3.7mm | In distribution |
| SHN 2010S | Ø3.1X3.0mm | In distribution |
| AMI 48355 | Ø3.5X5.5mm | In distribution |
| AAN 50225 | Ø6.0X2.0mm | In distribution |
| ACN 50623 | Ø5.5X2.0(Cuff)mm | In distribution |
| ABN 40502 | Ø4.5X2.0mm | In distribution |
| SHN 1403 | Ø1.4X3.7mm | In distribution |
| CHN 4001 | Ø4.3X5.8mm | In distribution |
| CHN 3500N | Ø1.6X4.2mm | In distribution |
| SHN 2012 | Ø2.95X4.0mm | In distribution |
| AHN 50605 | Ø6.0X5.0mm | In distribution |
| SHN 2010 | Ø2.95X2.0mm | In distribution |
| AHN 40505 | Ø5.0X5.0mm | In distribution |
| AHN 40506 | Ø5.0X6.0mm | In distribution |
| ABN 40503 | Ø4.5X3.0mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MEDENTiKA | Medentika GmbH | 2,553 |
| LW Vis Abutment | Ossvis Co., Ltd. | 2,520 |
| Dess dental smart solutions | Terrats Medical SL | 1,715 |
| Locator | Zest Anchors, LLC | 1,643 |
| NobelProcera® | Nobel Biocare AB | 1,526 |
| Azure | Terrats Medical SL | 1,360 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 1,308 |
| LW Vis Abutment SET | Ossvis Co., Ltd. | 1,260 |
| Abutment, Implant, Dental, Endosseous | Southern Implants (PTY) Ltd | 1,240 |
| Healing Abutment | Megagen Implant Co., Ltd. | 1,218 |
| Chaorum Implant System | Medimecca Co Ltd | 1,084 |
| OT Equator | Rhein 83 SRL | 1,051 |
Showing 12 of 6,204. All products under Abutment, Implant, Dental, Endosseous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220253 | 2023-08-18 |
| K193404 | 2020-05-18 |
| K192263 | 2020-02-21 |
| K190048 | 2019-09-30 |
| K181037 | 2018-12-21 |
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.