Primus Implant System
BIOTEM AR CEMENTED ABUTMENT(NON-HEX) 6.5mm X 1mm(cuff) X 7mm(height)
15manufacturers in China registered for this device type
116catalogue numbers in this listing
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 | Inosys, Inc., United States |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K171297 |
| Record published | 2022-06-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PBCA R6525N | In distribution | |
| PBCA R6535N | In distribution | |
| PBCA R4517H | In distribution | |
| PBCA R4517N | In distribution | |
| PBCA R6555H | In distribution | |
| PBCA M4537H | In distribution | |
| PBHA 602R | In distribution | |
| PBCA R4515H | In distribution | |
| PBCA R4545H | In distribution | |
| PBCA R6565N | In distribution | |
| PBHA 607R | In distribution | |
| PBCA R6545H | In distribution | |
| PBCA R6535H | In distribution | |
| PBHA 502R | In distribution | |
| PBCA R5565N | In distribution | |
| PBCA R6544N | In distribution | |
| PBCA R5544H | In distribution | |
| PBCA M4547H | In distribution | |
| PBHA 603R | In distribution | |
| PBHA 605R | In distribution | |
| PBCA R4524N | In distribution | |
| PBCA R4555H | In distribution | |
| PBCLS M | In distribution | |
| PBCA R6545N | In distribution | |
| PBCA R6555N | In distribution | |
| PBCA M4514H | In distribution | |
| PBCA R6537H | In distribution | |
| PBHA 505R | In distribution | |
| PBCA R4527H | In distribution | |
| PBCA R4534N | In distribution | |
| PBCA R6514N | In distribution | |
| PBCA R6525H | In distribution | |
| PBCA R4547N | In distribution | |
| PBCA R4524H | In distribution | |
| PBHA 407M | In distribution | |
| PBCA R5545N | In distribution | |
| PBCA R5544N | In distribution | |
| PBHA 403R | In distribution | |
| PBCA R6514H | In distribution | |
| PBCA R6517N | In distribution | |
| PBCA R6534N | In distribution | |
| PBCA R5524N | In distribution | |
| PBCA R6534H | In distribution | |
| PBCA R6517H | In distribution | |
| PBCA M4524H | In distribution | |
| PBCA R5517N | In distribution | |
| PBCA R5555N | In distribution | |
| PBHA 403M | In distribution | |
| PBCA R4515N | In distribution | |
| PBCA R5547H | In distribution | |
| PBCA M4525H | In distribution | |
| PBCA R5525H | In distribution | |
| PBCA R5524H | In distribution | |
| PBCA R4525H | In distribution | |
| PBHA 507R | In distribution | |
| PBCA R5537N | In distribution | |
| PBCA R5547N | In distribution | |
| PBCA R6544H | In distribution | |
| PBCA R5527N | In distribution | |
| PBCA R4547H | In distribution | |
| PBCA R4535N | In distribution | |
| PBCA M4515H | In distribution | |
| PBCA M4527H | In distribution | |
| PBCA M4517H | In distribution | |
| PBCA R6537N | In distribution | |
| PBCA R5535H | In distribution | |
| PBCA R5534H | In distribution | |
| PBCA R5565H | In distribution | |
| PBCA R6527N | In distribution | |
| PBCA R5514H | In distribution | |
| PBHA 705R | In distribution | |
| PBCA R5527H | In distribution | |
| PBCA M4535H | In distribution | |
| PBCA R4544H | In distribution | |
| PBCA R5515N | In distribution | |
| PBCA R4555N | In distribution | |
| PBCA R4537H | In distribution | |
| PBCA R4527N | In distribution | |
| PBCA R5545H | In distribution | |
| PBHA 703R | In distribution | |
| PBCA R4514N | In distribution | |
| PBCA M4544H | In distribution | |
| PBHA 503R | In distribution | |
| PBCA R4535H | In distribution | |
| PBCA R5537H | In distribution | |
| PBCA R5525N | In distribution | |
| PBCA R4537N | In distribution | |
| PBCA M4534H | In distribution | |
| PBCA R5534N | In distribution | |
| PBCA R5535N | In distribution | |
| PBCA R6547N | In distribution | |
| PBHA 702R | In distribution | |
| PBHA 707R | In distribution | |
| PBCA R4544N | In distribution | |
| PBCA R6515N | In distribution | |
| PBCA R4565N | In distribution | |
| PBCA R4565H | In distribution | |
| PBCA R4545N | In distribution | |
| PBCA R6565H | In distribution | |
| PBCA R4534H | In distribution | |
| PBCA R6524N | In distribution | |
| PBHA 405R | In distribution | |
| PBCA R6547H | In distribution | |
| PBCA R5555H | In distribution | |
| PBCA R6515H | In distribution | |
| PBCA R5514N | In distribution | |
| PBCA R6524H | In distribution | |
| PBCA R4514H | In distribution | |
| PBHA 407R | In distribution | |
| PBCA R4525N | In distribution | |
| PBHA 405M | In distribution | |
| PBCA R6527H | In distribution | |
| PBCA R5515H | In distribution | |
| PBCLS R | In distribution | |
| PBCA M4545H | In distribution | |
| PBCA R5517H | 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
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.