Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat EDENTA ETABLISSEMENT makes
Edenta Établissement manufactures reusable dental tools for clinical and laboratory use, including abrasive points, carbide and steel burs, abrasive disks, and laboratory mandrels. Their portfolio also includes dental restoration retention pins designed for precision fitting in restorative procedures.
All listed devices fall under Class I regulatory classification and are registered in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. regulatory requirements for these dental instruments.
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 Edenta Établissement manufacture?
Edenta Établissement specializes in reusable dental tools used in both clinical and laboratory settings. Their product range includes abrasive points, carbide and steel dental burs, abrasive disks, laboratory burs, laboratory mandrels, and dental restoration retention pins. These devices are designed for precision tasks like polishing, shaping, and retaining dental restorations.
Where is Edenta Établissement based, and what regulatory requirements do they follow?
Edenta Établissement is based in the United States. As a manufacturer of dental instruments, they operate under U.S. regulatory requirements, ensuring compliance with applicable standards for reusable medical devices. Their devices are registered in the FDA’s Unique Device Identifier (UDI) database, which helps track and identify these products within the regulatory system.
Which regulatory registries list Edenta Établissement’s devices?
Edenta Établissement’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to maintain a standardized identification system for medical devices, ensuring traceability and transparency in the regulatory process. The UDI system helps healthcare providers, regulators, and other stakeholders verify and track the devices.
How are Edenta Établissement’s devices classified under U.S. regulations?
All of Edenta Établissement’s listed devices fall under Class I regulatory classification in the U.S. This classification applies to low-risk devices that pose minimal potential harm to users. Class I devices typically require general controls (such as good manufacturing practices) but do not require pre-market approval or additional scrutiny beyond registration and labeling compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 448002915
Catalogue (1581)
Page 27 of 32| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Edenta | 355.514.220UM | FDA UDI | Class I | Active |
| Edenta | 5022HP | FDA UDI | Class I | Active |
| Edenta | WC10-12 | FDA UDI | Class I | Active |
| Edenta | BF733.035HP-12 | FDA UDI | Class I | Active |
| Edenta | 0672HP-100 | FDA UDI | Class I | Active |
| Edenta | 355.514.160HP | FDA UDI | Class I | Active |
| Edenta | 1423UM-50 | FDA UDI | Class I | Active |
| Edenta | PC11-100 | FDA UDI | Class I | Active |
| Edenta | 345.514.220HP | FDA UDI | Class I | Active |
| Edenta | 9006.220HP | FDA UDI | Class I | Active |
| Edenta | 21.104.021 | FDA UDI | Class I | Active |
| Edenta | N5.R2D.01 | FDA UDI | Class I | Active |
| Edenta | 0612HP | FDA UDI | Class I | Active |
| Edenta | 7800.123.010 | FDA UDI | Class I | Active |
| Edenta | 0141HP-100 | FDA UDI | Class I | Active |
| Edenta | 1123UM-10 | FDA UDI | Class I | Active |
| Edenta | 5856.104.023 | FDA UDI | Class I | Active |
| Edenta | 9001.140HP | FDA UDI | Class I | Active |
| Edenta | N7.G.01 | FDA UDI | Class I | Active |
| Edenta | 1810.023HP | FDA UDI | Class I | Active |
| Edenta | 2.104.007 | FDA UDI | Class I | Active |
| Edenta | 378.524.450HP | FDA UDI | Class I | Active |
| Edenta | 958.035HP | FDA UDI | Class I | Active |
| Edenta | TB47-100 | FDA UDI | Class I | Active |
| Edenta | 7001.220UM-25 | FDA UDI | Class I | Active |
| Edenta | 5209HP | FDA UDI | Class I | Active |
| Edenta | DISC40.220HP | FDA UDI | Class I | Active |
| Edenta | PC01-12 | FDA UDI | Class I | Active |
| Edenta | N1.R2D.21 | FDA UDI | Class I | Active |
| Edenta | WF11-12 | FDA UDI | Class I | Active |
| Edenta | GM731.065HP-12 | FDA UDI | Class I | Active |
| Edenta | AM73-100 | FDA UDI | Class I | Active |
| Edenta | T5848L.104.023 | FDA UDI | Class I | Active |
| Edenta | 2635.103.015 | FDA UDI | Class I | Active |
| Edenta | 0340HP-100 | FDA UDI | Class I | Active |
| Edenta | TC30.104.012 | FDA UDI | Class I | Active |
| Edenta | WC01-12 | FDA UDI | Class I | Active |
| Edenta | 0511UM-100 | FDA UDI | Class I | Active |
| Edenta | 2666F.123.010 | FDA UDI | Class I | Active |
| Edenta | TB23-12 | FDA UDI | Class I | Active |
| Edenta | 0307UM-100 | FDA UDI | Class I | Active |
| Edenta | 6801.104.035 | FDA UDI | Class I | Active |
| Edenta | 0043HP-12 | FDA UDI | Class I | Active |
| Edenta | 1813UM-100 | FDA UDI | Class I | Active |
| Edenta | 0149HP-6 | FDA UDI | Class I | Active |
| Edenta | 5580.060HP | FDA UDI | Class I | Active |
| Edenta | N1.R2C.01 | FDA UDI | Class I | Active |
| Edenta | AM76-6 | FDA UDI | Class I | Active |
| Edenta | PIN0210-1000 | FDA UDI | Class I | Active |
| Edenta | K861.104.014 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.