Imtec
Deluxe Small Diameter Surgical Kit
70manufacturers in China registered for this device type
55catalogue 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 | Park Dental Research Corp, United States |
|---|---|
| FDA product code | NDP |
| Device type | Accessories, Implant, Dental, Endosseous |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3980 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-05-06 |
| Record revised | 2026-04-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2026-04-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4118 | In distribution | ||
| 0350-10 | In distribution | ||
| 1015 | In distribution | ||
| IM-XP9025DL | In distribution | ||
| MH-1 | In distribution | ||
| 2924 | In distribution | ||
| 1803 | In distribution | ||
| IM-P1750 | In distribution | ||
| 2921 | In distribution | ||
| 0550-25 | In distribution | ||
| IM-CASE-3 | In distribution | ||
| IM-P1737 | In distribution | ||
| 8028 | In distribution | ||
| IM-SVKIT-XP | In distribution | ||
| 0150 | In distribution | ||
| CASE-7 | In distribution | ||
| IM-JGUN-1 | In distribution | ||
| IM-P1742 | In distribution | ||
| IM-P9051 | In distribution | ||
| MH-2 | In distribution | ||
| 1804 | In distribution | ||
| 1010 | In distribution | ||
| IM-LEW-002 | In distribution | ||
| 1003 | In distribution | ||
| MH-3 | In distribution | ||
| 1025 | In distribution | ||
| MH-24 | In distribution | ||
| 8720 | In distribution | ||
| IM-P9041 | In distribution | ||
| IM-P9033 | In distribution | ||
| IM-LEW-001 | In distribution | ||
| 0250 | In distribution | ||
| 2924-10 | 10 | In distribution | |
| IM-LEW-001A | In distribution | ||
| 8730 | In distribution | ||
| 0300 | In distribution | ||
| 1020 | In distribution | ||
| IM-BNC-1 | In distribution | ||
| MH-34 | In distribution | ||
| 0200 | In distribution | ||
| IM-8701 | In distribution | ||
| IM-LEW-004 | In distribution | ||
| LAXO | In distribution | ||
| 1802 | In distribution | ||
| LACO | In distribution | ||
| IM-Lew-003 | In distribution | ||
| 0350-25 | In distribution | ||
| 0550-10 | In distribution | ||
| 0450-10 | In distribution | ||
| SVKIT | In distribution | ||
| IM-P9038 | In distribution | ||
| 1012 | In distribution | ||
| MH-14 | In distribution | ||
| IM-CASE-1 | Withdrawn | ||
| IM-SVKIT-MT | 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.