TruScan Body
136 catalogue numbers from DX34-SB, listed by TruAbutment Korea Co., Ltd., 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
136catalogue 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 | TruAbutment Korea Co., Ltd., South Korea |
|---|---|
| FDA product code | NDP |
| Device type | Accessories, Implant, Dental, Endosseous |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3980 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-03-16 |
| Record revised | 2026-03-13 (version 2) |
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 |
|---|---|---|
| DX34-SB | In distribution | |
| ZVN-SB | In distribution | |
| DSU-SB | In distribution | |
| AE48-MSB | In distribution | |
| SBN-SB | In distribution | |
| BH57-MSB | In distribution | |
| AS3-MSB | In distribution | |
| IDL30-SB | In distribution | |
| DX55-SB | In distribution | |
| OTR-MSB | In distribution | |
| KPS-MSB | In distribution | |
| BC60-SB | In distribution | |
| CA60-SB | In distribution | |
| BH45-MSB | In distribution | |
| STW-MSB | In distribution | |
| CN43-MSB | In distribution | |
| ZV5-MSB | In distribution | |
| NAW-SB | In distribution | |
| OTM-SB | In distribution | |
| CN38-SB | In distribution | |
| AS4-SB | In distribution | |
| OTR-SB | In distribution | |
| KPW-MSB | In distribution | |
| BC34-MSB | In distribution | |
| NSN-SB | In distribution | |
| NSR-MSB | In distribution | |
| NRN-MSB | In distribution | |
| ZV4-SB | In distribution | |
| CA50-SB | In distribution | |
| NAR-MSB | In distribution | |
| DUR-MSB | In distribution | |
| CN43-SB | In distribution | |
| KPR-SB | In distribution | |
| AE54-MSB | In distribution | |
| NRR-MSB | In distribution | |
| DSU-MSB | In distribution | |
| BH35-SB | In distribution | |
| IDL30-MSB | In distribution | |
| AS3-SB | In distribution | |
| ZVN-MSB | In distribution | |
| MRD-SB | In distribution | |
| CA33-SB | In distribution | |
| BC34-SB | In distribution | |
| KPS-SB | In distribution | |
| SBS-MSB | In distribution | |
| MRD-SB-S | In distribution | |
| AE36-MSB | In distribution | |
| CA33-MSB | In distribution | |
| ZV3-MSB | In distribution | |
| NR6-SB | In distribution | |
| DUN-MSB | In distribution | |
| NDG-MSB | In distribution | |
| NAW-MSB | In distribution | |
| BHN-MSB | In distribution | |
| NDGN-MSB | In distribution | |
| AE30-MSB | In distribution | |
| BH45-SB | In distribution | |
| MCN-MSB | In distribution | |
| NAR-SB | In distribution | |
| AS5-SB | In distribution | |
| KPW-SB | In distribution | |
| CA50-MSB | In distribution | |
| NSR-SB | In distribution | |
| MCN-SB | In distribution | |
| MRD-MSB | In distribution | |
| NR6-MSB | In distribution | |
| ZV4-MSB | In distribution | |
| AE30-SB | In distribution | |
| MCW-SB | In distribution | |
| CN38-MSB | In distribution | |
| CN33-MSB | In distribution | |
| NDG-SB | In distribution | |
| AE42-MSB | In distribution | |
| DX38-SB | In distribution | |
| BC41-MSB | In distribution | |
| NRW-SB | In distribution | |
| CA43-MSB | In distribution | |
| CN33-SB | In distribution | |
| STW-SB | In distribution | |
| SBR-MSB | In distribution | |
| MBN-MSB | In distribution | |
| OTM-MSB | In distribution | |
| MCS-MSB | In distribution | |
| MBR-MSB | In distribution | |
| MCW-MSB | In distribution | |
| NRW-MSB | In distribution | |
| STXN-SB | In distribution | |
| NA3-SB | In distribution | |
| STR-MSB | In distribution | |
| AE36-SB | In distribution | |
| NAN-SB | In distribution | |
| CA38-SB | In distribution | |
| NDC-SB | In distribution | |
| NAN-MSB | In distribution | |
| MCS-SB | In distribution | |
| SBN-MSB | In distribution | |
| ZV5-SB | In distribution | |
| SBR-SB | In distribution | |
| SXR-SB | In distribution | |
| NSN-MSB | In distribution | |
| AS4-MSB | In distribution | |
| CA43-SB | In distribution | |
| NDC-MSB | In distribution | |
| ZV3-SB | In distribution | |
| NRN-SB | In distribution | |
| CN50-SB | In distribution | |
| DQR-SB | In distribution | |
| BH35-MSB | In distribution | |
| AE54-SB | In distribution | |
| STXN-MSB | In distribution | |
| KRS-SB | In distribution | |
| BC60-MSB | In distribution | |
| BC41-SB | In distribution | |
| BHN-SB | In distribution | |
| BH57-SB | In distribution | |
| DQN-SB | In distribution | |
| NDGN-SB | In distribution | |
| DX45-SB | In distribution | |
| NA3-MSB | In distribution | |
| SXR-MSB | In distribution | |
| AE42-SB | In distribution | |
| NRR-SB | In distribution | |
| DX30-SB | In distribution | |
| DUR-SB | In distribution | |
| BC50-MSB | In distribution | |
| SBS-SB | In distribution | |
| DUN-SB | In distribution | |
| STR-SB | In distribution | |
| BC50-SB | In distribution | |
| CN50-MSB | In distribution | |
| CA38-MSB | In distribution | |
| CA60-MSB | In distribution | |
| AS5-MSB | In distribution | |
| AE48-SB | In distribution | |
| KPR-MSB | In distribution | |
| KRR-SB | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Truabutment Inc. | UDI-DI | 2023-12-27 | Class II | Unknown/Undetermined by firm | Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately | 61 units |
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.