3shape Scan Bodies
ASTRA TECH - Regular platform - Connection: Large (4.5, 5.0)
70manufacturers in China registered for this device type
119catalogue 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 | 3SHAPE Trios A/S, Denmark |
|---|---|
| FDA product code | NDP |
| Device type | Accessories, Implant, Dental, Endosseous |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3980 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-06-13 |
| Record revised | 2023-04-04 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Outer diameter 3 to 7 mm; length 3.5 to 5 mm |
| Distribution end date | 2021-07-16 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BCsys | In distribution | |
| NG | In distribution | |
| NBN | Outer Diameter 3.4 mm | In distribution |
| NRR | Outer Diameter 3.7 mm | In distribution |
| BIY | Outer Diameter 3.5 mm | In distribution |
| DEG | Outer Diameter 3.0 mm | In distribution |
| NAW | Outer Diameter 4.7 mm | In distribution |
| ZTG | Outer Diameter 3.5 mm | In distribution |
| NCG | Length 4.0 mm | In distribution |
| NA | In distribution | |
| NCsys | In distribution | |
| SBN | Outer Diameter 3.0 mm | In distribution |
| NRW | Outer Diameter 4.2 mm | In distribution |
| DAL | Outer Diameter 5.0 mm | In distribution |
| NCY | Length 4.3 mm | In distribution |
| NR6 | Outer Diameter 6.0 mm | In distribution |
| CCB | Outer Diameter 5.0 mm | In distribution |
| DAS | Outer Diameter 4.0 mm | In distribution |
| NBW | Outer Diameter 5.0 mm | In distribution |
| BIB | Outer Diameter 5.7 mm | In distribution |
| CC6 | Outer Diameter 6.0 mm | In distribution |
| ZTsys | In distribution | |
| BEB | Outer Diameter 3.75 mm | In distribution |
| OT | In distribution | |
| NB | In distribution | |
| DXsys | In distribution | |
| DEB | Outer Diameter 4.8 mm | In distribution |
| CCP | Outer Diameter 4.3 mm | In distribution |
| NGG | Length 4.0 mm | In distribution |
| DAX | Outer Diameter 3.0 mm | In distribution |
| SSW | Outer Diameter 6.5 mm | In distribution |
| BEG | Outer Diameter 6.0 mm | In distribution |
| NR | In distribution | |
| SB | In distribution | |
| NRN | Outer Diameter 3.4 mm | In distribution |
| SBR | Outer Diameter 3.75 mm | In distribution |
| DYB | Outer Diameter 5.5 mm | In distribution |
| NGP | Length 3.5 mm | In distribution |
| NAR | Outer Diameter 3.5 mm | In distribution |
| DEP | Outer Diameter 3.6 mm | In distribution |
| SSR | Outer Diameter 4.8 mm | In distribution |
| DXB | Outer Diameter 4.5 mm | In distribution |
| NG6 | Outer Diameter 6.0 mm | In distribution |
| OTM | Outer Diameter 3.0 mm | In distribution |
| DXG | Outer Diameter 3.4 mm | In distribution |
| SBsys | In distribution | |
| BCY | Outer Diameter 5.0 mm | In distribution |
| SSN | Outer Diameter 3.5 mm | In distribution |
| DXbox | In distribution | |
| DAsys | In distribution | |
| BIsys | In distribution | |
| DXR | Outer Diameter 5.5 mm | In distribution |
| NGB | Outer Diameter 3.75 mm | In distribution |
| DXY | Outer Diameter 3.8 mm | In distribution |
| NRDsys | In distribution | |
| CCsys | In distribution | |
| CC | In distribution | |
| ZTY | Outer Diameter 5.7 mm | In distribution |
| ZTP | Outer Diameter 4.5 mm | In distribution |
| SS | In distribution | |
| DX | In distribution | |
| DYR | Outer Diameter 3.5 mm | In distribution |
| NGY | Length 4.3 mm | In distribution |
| NAN | Outer Diameter 3.1 mm | In distribution |
| DE | In distribution | |
| BC | In distribution | |
| NBsys | In distribution | |
| OTR | Outer Diameter 3.5 mm | In distribution |
| BIG | Outer Diameter 4.5 mm | In distribution |
| DYG | Outer Diameter 7.0 mm | In distribution |
| DX3 | Outer Diameter 3.0 mm | In distribution |
| CCY | Outer Diameter 3.8 mm | In distribution |
| ZT | In distribution | |
| BCG | Outer Diameter 6.0 mm | In distribution |
| NCP | Outer Diameter 3.5 mm | In distribution |
| BCP | Outer Diameter 3.4 mm | In distribution |
| NBR | Outer Diameter 3.75 mm | In distribution |
| NAsys | In distribution | |
| DYsys | In distribution | |
| BE | In distribution | |
| DA | In distribution | |
| NCB | Length 3.75 mm | In distribution |
| BI3 | Outer Diameter 3.0 mm | In distribution |
| NG5 | Outer Diameter 5.0 mm | In distribution |
| OTsys | In distribution | |
| BI | In distribution | |
| NA3 | Outer Diameter 3.0 mm | In distribution |
| BEP | Outer Diameter 3.25 mm | In distribution |
| NGsys | In distribution | |
| DEY | Outer Diameter 4.2 mm | In distribution |
| BCB | Outer Diameter 4.1 mm | In distribution |
| CCG | Outer Diameter 3.3 mm | In distribution |
| DYY | Outer Diameter 4.5 mm | In distribution |
| BE4 | Outer Diameter 4.0 mm | In distribution |
| BEY | Outer Diameter 5.0 mm | In distribution |
| DY | In distribution | |
| DE5 | Outer Diameter 5.4 mm | In distribution |
| DEsys | In distribution | |
| BEsys | In distribution | |
| NC5 | Length 5.0 mm | In distribution |
| NC | In distribution | |
| CCbox | Withdrawn | |
| OTbox | Withdrawn | |
| NBbox | Withdrawn | |
| DAbox | Withdrawn | |
| DEbox | Withdrawn | |
| NAbox | Withdrawn | |
| BIbox | Withdrawn | |
| ZTbox | Withdrawn | |
| BCbox | Withdrawn | |
| NRDbox | Withdrawn | |
| NGbox | Withdrawn | |
| NRbox | Withdrawn | |
| DYbox | Withdrawn | |
| SBDbox | Withdrawn | |
| SSbox | Withdrawn | |
| BEbox | Withdrawn | |
| NCbox | Withdrawn | |
| SBbox | Withdrawn |
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
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.