Simplant®
C/Guide Sleeve 5.2 WD PrimeTaper/OmniTaper/AstraTech Impl EV
70manufacturers in China registered for this device type
72catalogue 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 | Dentsply Implants Manufacturing GmbH, Germany |
|---|---|
| FDA product code | NDP |
| Device type | Accessories, Implant, Dental, Endosseous |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3980 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-17 |
| Record revised | 2026-01-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2026-01-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31830740 | In distribution | |
| 54500114 | In distribution | |
| 54500124 | In distribution | |
| 31830748 | In distribution | |
| 54500122 | In distribution | |
| 31830746 | In distribution | |
| 54500129 | In distribution | |
| 54500120 | In distribution | |
| 54500118 | In distribution | |
| 31830731 | In distribution | |
| 54500194 | In distribution | |
| 54500185 | In distribution | |
| 54500187 | In distribution | |
| 54500126 | In distribution | |
| 54500127 | In distribution | |
| 31830737 | In distribution | |
| 37522 | In distribution | |
| 54500197 | In distribution | |
| 54500130 | In distribution | |
| 37473 | In distribution | |
| 54500115 | In distribution | |
| 31830745 | In distribution | |
| 31830749 | In distribution | |
| 54500123 | In distribution | |
| 54500105 | In distribution | |
| 68017305 | In distribution | |
| 68017212 | In distribution | |
| 68017221 | In distribution | |
| 31830738 | In distribution | |
| 68017217 | In distribution | |
| 68017215 | In distribution | |
| 31830736 | In distribution | |
| 54500175 | In distribution | |
| 68017222 | In distribution | |
| 31830747 | In distribution | |
| 31830743 | In distribution | |
| 54500180 | In distribution | |
| 31830750 | In distribution | |
| 31830730 | In distribution | |
| 31830751 | In distribution | |
| 54500119 | In distribution | |
| 54500128 | In distribution | |
| 54500214 | In distribution | |
| 31830744 | In distribution | |
| 68017218 | In distribution | |
| 54500117 | In distribution | |
| 31830739 | In distribution | |
| 54500125 | In distribution | |
| 31830729 | In distribution | |
| 37521 | In distribution | |
| 68017208 | In distribution | |
| 68017207 | In distribution | |
| 68017223 | In distribution | |
| 54500179 | In distribution | |
| 68017216 | In distribution | |
| 68017211 | In distribution | |
| 68017220 | In distribution | |
| 68017214 | In distribution | |
| 68017210 | In distribution | |
| 37472 | In distribution | |
| 68017219 | In distribution | |
| 54500113 | In distribution | |
| 31830728 | In distribution | |
| 54500121 | In distribution | |
| 68017213 | In distribution | |
| 54500104 | In distribution | |
| 54500173 | In distribution | |
| 54500116 | In distribution | |
| 31830734 | Withdrawn | |
| 31830733 | Withdrawn | |
| 31830732 | Withdrawn | |
| 31830735 | 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.