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Sign in to claim this brandVDW GmbH
US
Last updated May 25, 2026
What VDW GmbH makes
VDW GmbH manufactures endodontic devices focused on root canal treatment, including handheld apex locators for determining the working length of teeth during procedures. Their portfolio also includes rechargeable batteries, chargers, and accessories like measuring cables and file/lip clips designed to support precision in dental endodontics.
The company’s products are classified as Class U devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. VDW GmbH is based in the United States.
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 VDW GmbH manufacture?
VDW GmbH specializes in endodontic devices, primarily focusing on tools used in root canal treatment. Their most common product category is the endodontic apex locator, which helps dental professionals determine the precise working length of a tooth during procedures. They also produce related accessories like rechargeable batteries, chargers, measuring cables, and clips to support these treatments.
Where is VDW GmbH based?
VDW GmbH is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.
Which regulatory registries list VDW GmbH’s devices?
VDW GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices under FDA oversight, allowing healthcare providers and regulators to identify and verify the devices in use.
How are VDW GmbH’s devices classified under FDA regulations?
VDW GmbH’s devices are classified as Class U under FDA regulations. Class U devices are generally considered lower risk and are exempt from certain premarket review requirements, though they still must comply with general controls and labeling regulations to ensure safety and effectiveness.
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
- —
- DUNS Number
- 316138895
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Promark Touch Probe | V841119000518 | FDA UDI | U | Active |
| Promark Rechargeable Nimh Battery | V841119000507 | FDA UDI | U | Active |
| Promark Charger | V841119000501 | FDA UDI | U | Active |
| Promark Measuring Cable | V841119000506 | FDA UDI | U | Active |
| Promark File Clip | V841119000515 | FDA UDI | U | Active |
| Promark Lip Clip | V841119000514 | FDA UDI | U | Active |
| Promark Apex Locator | V841113000000 | FDA UDI | U | Active |
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