Master Fix
Master Fix is a titanium base used as part of a two-piece dental implant abutment. It supports a custom zirconia superstructure, connecting the planned prosthetic restoration to a…
Master Fix is a titanium base used as part of a two-piece dental implant abutment. It supports a custom zirconia superstructure, connecting the planned prosthetic restoration to a compatible implant in the upper or lower jaw.
The pre-manufactured titanium alloy base and the CAD/CAM zirconia superstructure are cemented together. A separate Master Fix screw connects the resulting abutment to the implant fixture.
Connection and Fabrication
Two flat surfaces help prevent rotation between the base and zirconia, and a slot in the post provides area for cement adhesion. The custom superstructure is straight and is manufactured at an ARUM-validated milling center. Master Fix configurations support the NB 1 SA and NB implant systems.
15manufacturers in China registered for this device type
160catalogue numbers in this listing
6510(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 | Arum Dentistry Co., Ltd., South Korea |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Manufacturer |
| 510(k) | K240603 |
| Record published | 2025-01-20 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SALN5523RP | In distribution | |
| SDM_M4015TN | In distribution | |
| SDM_M4515TN | In distribution | |
| NBR_M5525THP | In distribution | |
| SDM_M4525TH | In distribution | |
| SDR_M4515THP | In distribution | |
| SALN5513RP | In distribution | |
| SDR_M5535THP | In distribution | |
| SDM_M4025TH | In distribution | |
| SALH4525RP | In distribution | |
| SALH4545RP | In distribution | |
| SALH6533RP | In distribution | |
| SALH5543RP | In distribution | |
| SDR_M5535TN | In distribution | |
| SALN4553RP | In distribution | |
| SDM_M4555TN | In distribution | |
| SALH5545RP | In distribution | |
| SALH4523RP | In distribution | |
| SDR_M4535THP | In distribution | |
| SDM_M4045TH | In distribution | |
| SALH5555RP | In distribution | |
| SDM_M4035TN | In distribution | |
| SDM_M4515TH | In distribution | |
| SDM_M4045THP | In distribution | |
| SDR_M5525TN | In distribution | |
| NBR_M4545THP | In distribution | |
| SDM_M4535THP | In distribution | |
| SDM_M4545TH | In distribution | |
| SDM_M4055THP | In distribution | |
| SDM_M4025TN | In distribution | |
| SDM_M4515THP | In distribution | |
| SALN6555RP | In distribution | |
| SALH6555RP | In distribution | |
| SDM_M4545THP | In distribution | |
| SDM_M4535TH | In distribution | |
| SALH4513RP | In distribution | |
| SDR_M4525TH | In distribution | |
| NBR_M5555TNP | In distribution | |
| SALH6513RP | In distribution | |
| SDR_M4555TH | In distribution | |
| SALH5533RP | In distribution | |
| SDM_M4035TH | In distribution | |
| SALH6535RP | In distribution | |
| SDR_M4515TN | In distribution | |
| SDM_M4035TNP | In distribution | |
| SDR_M4515TNP | In distribution | |
| SDR_M5545TN | In distribution | |
| SDR_M5545TH | In distribution | |
| SALN6533RP | In distribution | |
| SALN4515RP | In distribution | |
| NBR_M5545TNP | In distribution | |
| SDM_M4525TN | In distribution | |
| SALH6545RP | In distribution | |
| SDM_M4555THP | In distribution | |
| SALN4545RP | In distribution | |
| SDM_M4545TNP | In distribution | |
| SDM_M4055TNP | In distribution | |
| SALN4555RP | In distribution | |
| SDM_M4555TH | In distribution | |
| SDR_M5555THP | In distribution | |
| SDR_M4545THP | In distribution | |
| NBR_M4535THP | In distribution | |
| SALH6553RP | In distribution | |
| SALH5523RP | In distribution | |
| SALN5555RP | In distribution | |
| SALN5515RP | In distribution | |
| SALN6553RP | In distribution | |
| NBR_M4525THP | In distribution | |
| SDR_M5555TNP | In distribution | |
| SALN6543RP | In distribution | |
| SALH4515RP | In distribution | |
| NBR_M4525TNP | In distribution | |
| SDM_M4525TNP | In distribution | |
| SALN5553RP | In distribution | |
| SDM_M4535TN | In distribution | |
| NBR_M4555THP | In distribution | |
| SDR_M4545TN | In distribution | |
| SDM_M4025TNP | In distribution | |
| SDR_M5525TNP | In distribution | |
| SALN5545RP | In distribution | |
| SDR_M5515TH | In distribution | |
| SDR_M4525TNP | In distribution | |
| SALN5535RP | In distribution | |
| SDR_M5555TH | In distribution | |
| SALN4543RP | In distribution | |
| SDM_M4555TNP | In distribution | |
| SDR_M5555TN | In distribution | |
| SDM_M4045TN | In distribution | |
| SALH6523RP | In distribution | |
| SDM_M4515TNP | In distribution | |
| SALH6543RP | In distribution | |
| SDM_M4545TN | In distribution | |
| SDR_M5535TH | In distribution | |
| NBR_M5535TNP | In distribution | |
| SALH4543RP | In distribution | |
| SDR_M5515TNP | In distribution | |
| SDR_M5515THP | In distribution | |
| SDM_M4045TNP | In distribution | |
| SALN5533RP | In distribution | |
| SDR_M5545TNP | In distribution | |
| NBR_M4545TNP | In distribution | |
| SDR_M5525TH | In distribution | |
| SDM_M4015THP | In distribution | |
| SALN4513RP | In distribution | |
| SALN6545RP | In distribution | |
| NBR_M4515THP | In distribution | |
| SDM_M4035THP | In distribution | |
| SDR_M5525THP | In distribution | |
| SDR_M4545TH | In distribution | |
| SDM_M4055TN | In distribution | |
| SALH5513RP | In distribution | |
| SALN6525RP | In distribution | |
| SDM_M4055TH | In distribution | |
| SDR_M4555TNP | In distribution | |
| NBR_M5515THP | In distribution | |
| SALH5515RP | In distribution | |
| SDM_M4025TH | In distribution | |
| SALN4525RP | In distribution | |
| SALH6525RP | In distribution | |
| SDM_M4015TH | In distribution | |
| NBR_M4515TNP | In distribution | |
| SDM_M4535TNP | In distribution | |
| NBR_M5535THP | In distribution | |
| SDM_M4525THP | In distribution | |
| SDR_M4535TH | In distribution | |
| NBR_M5545THP | In distribution | |
| SDR_M4555TN | In distribution | |
| NBR_M5555THP | In distribution | |
| SDR_M4515TH | In distribution | |
| SALH5535RP | In distribution | |
| SALN4523RP | In distribution | |
| SALN6523RP | In distribution | |
| SALH4553RP | In distribution | |
| SALN4535RP | In distribution | |
| NBR_M4535TNP | In distribution | |
| SALN6513RP | In distribution | |
| SDR_M4535TN | In distribution | |
| SDR_M4525TN | In distribution | |
| NBR_M5515TNP | In distribution | |
| SDR_M4525THP | In distribution | |
| SALN5543RP | In distribution | |
| SALH5553RP | In distribution | |
| SDR_M5535TNP | In distribution | |
| SALH6515RP | In distribution | |
| SALN4533RP | In distribution | |
| SDR_M4535TNP | In distribution | |
| SALN6535RP | In distribution | |
| SALH4555RP | In distribution | |
| SALN5525RP | In distribution | |
| SDM_M4015TNP | In distribution | |
| SALH4535RP | In distribution | |
| SDR_M4555THP | In distribution | |
| SALH4533RP | In distribution | |
| SDR_M5515TN | In distribution | |
| SALH5525RP | In distribution | |
| SDR_M5545THP | In distribution | |
| SALN6515RP | In distribution | |
| NBR_M5525TNP | In distribution | |
| NBR_M4555TNP | In distribution | |
| SDR_M4545TNP | 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 |
|---|---|
| K242245 | 2024-11-25 |
| K240603 | 2024-06-05 |
| K234112 | 2024-05-09 |
| K232560 | 2023-12-19 |
| K223634 | 2023-04-28 |
| K193425 | 2020-03-09 |
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.