Impression Coping
59 catalogue numbers from 3.03.073, listed by Thommen Medical, AG, Switzerland, under Accessories, Implant, Dental, Endosseous. 70 manufacturers in China are registered for this product code.
70manufacturers in China registered for this device type
59catalogue numbers in this listing
1510(k) clearance
2recalls on this code
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 | Thommen Medical, AG, Switzerland |
|---|---|
| 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 | 2020-07-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3.03.073 | In distribution | |
| 3.03.015 | In distribution | |
| 3.03.011 | In distribution | |
| 3.04.032 | In distribution | |
| 3.04.049 | In distribution | |
| 3.04.024 | In distribution | |
| 3.03.573 | In distribution | |
| 3.04.046 | In distribution | |
| 3.03.079 | In distribution | |
| 2.03.703 | In distribution | |
| 2.03.702 | In distribution | |
| 3.04.038 | In distribution | |
| 3.03.078 | In distribution | |
| 3.03.010 | In distribution | |
| 3.03.071 | In distribution | |
| 3.04.048 | In distribution | |
| 3.04.028 | In distribution | |
| 3.04.033 | In distribution | |
| 3.04.023 | In distribution | |
| 2.03.701 | In distribution | |
| 3.04.037 | In distribution | |
| 3.03.101 | In distribution | |
| 2.03.705 | In distribution | |
| 3.03.016 | In distribution | |
| 3.03.019 | In distribution | |
| 3.04.050 | In distribution | |
| 2.03.709 | In distribution | |
| 3.03.576 | In distribution | |
| 3.03.581 | In distribution | |
| 3.03.076 | In distribution | |
| 3.03.013 | In distribution | |
| 3.03.017 | In distribution | |
| 3.04.021 | In distribution | |
| 2.03.707 | In distribution | |
| 3.04.030 | In distribution | |
| 3.03.014 | In distribution | |
| 3.04.039 | In distribution | |
| 3.03.075 | In distribution | |
| 3.04.047 | In distribution | |
| 3.03.072 | In distribution | |
| 3.03.572 | In distribution | |
| 3.04.040 | In distribution | |
| 2.03.700 | In distribution | |
| 3.03.077 | In distribution | |
| 2.03.706 | In distribution | |
| 3.03.574 | In distribution | |
| 3.03.801 | In distribution | |
| 3.04.020 | In distribution | |
| 3.03.012 | In distribution | |
| 3.04.022 | In distribution | |
| 3.03.074 | In distribution | |
| 3.04.034 | In distribution | |
| 2.03.704 | In distribution | |
| 3.03.577 | In distribution | |
| 3.03.580 | In distribution | |
| 3.03.575 | In distribution | |
| 2.03.708 | In distribution | |
| 3.03.018 | In distribution | |
| 3.04.031 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K070290 | 2007-04-17 |
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 |
|---|---|---|---|---|---|---|
| Thommen Medical, AG | UDI-DI | 2024-01-24 | Class II | Process change control | The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant. | 20 units |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-04-03 | Class II | Under Investigation by firm | Dental adaptor does not conform to specifications. The dental coupling of the adapter can become deformed when being inserted into the implant may make it difficult to remove the adapter from its counterpart (e.g. the handpiece). | 15 US | 2019-08-12 |
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.