OrangeCAD Med
OrangeCAD Med provides straight multi-unit abutments, healing abutments and related prosthetic components for compatible Straumann Bone Level implants. These parts support implant-based…
OrangeCAD Med provides straight multi-unit abutments, healing abutments and related prosthetic components for compatible Straumann Bone Level implants. These parts support implant-based restorations in the upper or lower jaw.
The multi-unit base connects directly to the implant with an integral screw. Its second part, a coping or healing cap, is retained by a prosthetic screw; a listed multi-unit coping belongs to this upper component group.
Listed Item
Multi-Unit Coping CAD/CAM AS
Healing and Material Configuration
Healing abutments are one-part components that attach directly to an individual implant. The described bases have nonindexed connections and straight designs. Abutments and prosthetic components are premanufactured from Ti-6Al-4V ELI titanium alloy and supplied nonsterile.
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 | Orangecad MED Gmbh, Germany |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K253312 |
| Record published | 2026-01-09 |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SMBL2706H | Compatible: Straumann® – Bone Level; RC | In distribution |
| SMBL5301H | Compatible: MUA Coping CAD/CAM | In distribution |
| SMBL5002H | Compatible: Straumann® – Bone Level; NC | In distribution |
| SMBL5001H | Compatible: Straumann® – Bone Level; NC | In distribution |
| SMBL2708H | Compatible: Straumann® – Bone Level; RC | In distribution |
| SMBL5007H | Compatible: Straumann® – Bone Level; RC | In distribution |
| SMBL5401H | Compatible: MUA Ø4.8 | H2.3 | M1.4 | In distribution |
| SMBL2707H | Compatible: Straumann® – Bone Level; RC | In distribution |
| SMBL5009H | Compatible: Straumann® – Bone Level; RC | In distribution |
| IPS-14-41 | Compatible: MUA Coping CAD/CAM AS | In distribution |
| SMBL5004H | Compatible: Straumann® – Bone Level; NC | In distribution |
| SMBL5008H | Compatible: Straumann® – Bone Level; RC | In distribution |
| SMBL5010H | Compatible: Straumann® – Bone Level; RC | In distribution |
| SMBL5201H | Compatible: MUA Ø4.8 | H2.3 | M1.4 | In distribution |
| SMBL5005H | Compatible: Straumann® – Bone Level; NC | In distribution |
| SMBL2704H | Compatible: Straumann® – Bone Level; NC | In distribution |
| 20.075.14 | Compatible: MUA Ø4.8 | H2.3 | M1.4 | In distribution |
| SMBL2703H | Compatible: Straumann® – Bone Level; NC | In distribution |
| SMBL5701H | Compatible: MUA Ø4.8 | H2.3 | M1.4 | In distribution |
| SMBL5006H | Compatible: Straumann® – Bone Level; RC | In distribution |
| SMBL5003H | Compatible: Straumann® – Bone Level; NC | In distribution |
| SMBL2705H | Compatible: Straumann® – Bone Level; NC | 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 |
|---|---|
| K253312 | 2025-12-23 |
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.