| Date | Description | Filesize |
|---|---|---|
| 07.03.2023 | General Terms and Conditions of Sale and Delivery | 101.49 KB |
| 18.05.2021 | Reseller Quality Assurance Conditions | 79.62 KB |
| 17.01.2018 | General Purchasing Conditions (Coltène/Whaledent AG) | 118.78 KB |
| 16.01.2019 | General Purchasing Conditions (Coltène/Whaledent GmbH & Co. KG) | 72.17 KB |
As a globally renowned manufacturer of dental medical devices, COLTENE is one of the first dental companies to fully comply with the requirements of the MDR (EC 745/2017) in Europe and was able to achieve a certificate for this at the beginning of 2020.
The worldwide acting quality management team also ensures that all products are always kept up to date with regards to the requirements for medical products.
This means that the COLTENE Group's customers can be confident that they are working exclusively with products that meet both the highest quality criteria and all regulatory requirements.
| Date | Description | Filesize |
|---|---|---|
| 25.05.2021 | EC Certificate | 290.69 KB |
| 28.04.2021 | Coltène/Whaledent AG MDSAP Certificate | 460.75 KB |
| 18.03.2021 | ISO 13485 Certificate | 382.37 KB |
| 11.08.2020 | EU MDR Certificate | 2.09 MB |
| Date | Description | Filesize |
|---|---|---|
| 27.07.2021 | EN ISO 13485 | 433.91 KB |
| 29.06.2021 | ISO 13485 : 2016 | 1.36 MB |
| 25.05.2021 | EC Design Examination Certificate haemostatic gelatine sponge | 1.26 MB |
| 06.08.2020 | Quality System root canal filling materials, paper points, aspirator tips, medicated gelatin sponges, root canal files, dental rotary handpiece with engine | 440.62 KB |
| 19.02.2020 | Quality System sterile covers, sterile sleeves for tubes | 204.29 KB |