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Sign in to claim this brandWhat Erkodent Erich Kopp GmbH makes
Erkodent Erich Kopp GmbH manufactures thermoplastic materials designed for dental appliance fabrication, including custom-fit aligners, bleaching trays, and retainers. Their portfolio includes products like Erkolen, Erkoloc-pro, and Erkoflex, which are used in orthodontic and cosmetic dental applications. Additional materials like Erkodur and Erkoplast PLA-W cater to specific dental fabrication needs, such as bleaching trays and aligner production.
These dental materials are classified as Class II (U) devices under FDA regulations and are listed in the FDA’s Unique Device Identification (UDI) system. The company operates from the United States, adhering to U.S. regulatory requirements for dental fabrication materials.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Erkodent Erich Kopp GmbH manufacture?
Erkodent Erich Kopp GmbH specializes in thermoplastic materials used for dental appliance fabrication. Their products, such as Erkolen, Erkoloc-pro, Erkoflex, and Erkodur, are primarily designed for creating custom-fit dental devices like aligners, bleaching trays, and retainers. These materials are tailored for orthodontic and cosmetic dental applications, ensuring precise and comfortable fits for patients.
Where is Erkodent Erich Kopp GmbH based, and how does this affect their devices?
Erkodent Erich Kopp GmbH is based in the United States. Since their devices are manufactured and sold within the U.S., they must comply with FDA regulations, including classification under the FDA’s device hierarchy. Their thermoplastic dental materials fall under Class II (U) classification, which means they are subject to specific controls to ensure safety and effectiveness before being listed in the FDA’s Unique Device Identification (UDI) system.
Which regulatory registries or databases list Erkodent Erich Kopp GmbH’s devices?
Erkodent Erich Kopp GmbH’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to verify the identity of their devices. Listing in the UDI system is a requirement for Class II devices in the U.S., ensuring compliance with regulatory standards.
How are Erkodent Erich Kopp GmbH’s dental materials classified under U.S. regulations?
Erkodent Erich Kopp GmbH’s thermoplastic dental materials are classified as Class II (U) devices under FDA regulations. This classification is based on their intended use—custom dental appliances like aligners and bleaching trays—which present moderate risks. Class II devices require special controls beyond general controls to mitigate risks, such as performance standards or post-market surveillance, ensuring they meet safety and effectiveness requirements before being authorized for use.
What kinds of dental devices are made using Erkodent Erich Kopp GmbH’s materials?
Erkodent Erich Kopp GmbH’s thermoplastic materials are used to fabricate a range of dental appliances, including clear aligners for orthodontic treatment, bleaching trays for teeth whitening, and retainers to maintain dental alignment. Products like Erkoloc-pro and Erkoflex are specifically designed for aligners and bleaching applications, while others like Erkodur cater to durable dental fabrication needs, ensuring versatility across different orthodontic and cosmetic procedures.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 317654200
Catalogue (165)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Erkoflex | 521254 | FDA UDI | U | Active |
| Erkodur-A1 | 522210 | FDA UDI | U | Active |
| Erkoflex | 581231 | FDA UDI | U | Active |
| Erkoflex | 581234 | FDA UDI | U | Active |
| Erkoloc-pro pink | 596950 | FDA UDI | U | Active |
| Erkoflex | 584253 | FDA UDI | U | Active |
| Erkoflex | 581247 | FDA UDI | U | Active |
| Erkoflex | 584234 | FDA UDI | U | Active |
| Erkodur freeze | 529130 | FDA UDI | U | Active |
| Erkoflex | 584254 | FDA UDI | U | Active |
| Erkoflex | 581228 | FDA UDI | U | Active |
| Erkoflex | 581948 | FDA UDI | U | Active |
| Erkoflex | 581242 | FDA UDI | U | Active |
| Erkoloc-pro green | 597430 | FDA UDI | U | Active |
| Erkodur-A1 | 521906 | FDA UDI | U | Active |
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