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Sign in to claim this brandDentmate Technology Co. , Ltd.
US
Last updated May 25, 2026
What Dentmate Technology Co. , Ltd. makes
Dentmate Technology Co., Ltd. manufactures dental and surgical polymerization lamps, including devices like the LEDEX and LUMINDEX series, which cure dental materials using visible light. They also produce visible-light skin transilluminators for medical examinations and fixed examination/treatment room lights designed for clinical use. These products are primarily used in dental and surgical settings to facilitate procedures requiring light-based curing or illumination.
The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories. These products are listed under the FDA’s 510(k) and UDI (Unique Device Identification) programs. The manufacturer 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 Dentmate Technology Co., Ltd. manufacture?
Dentmate Technology Co., Ltd. specializes in dental and surgical lighting devices. Their primary products include dental/surgical polymerization lamps, such as the LEDEX and LUMINDEX series, which cure dental materials using visible light. They also produce visible-light skin transilluminators for medical examinations and fixed examination/treatment room lights for clinical use. These devices are designed for use in dental offices, surgical settings, and other healthcare environments where precise lighting or curing is required.
Where is Dentmate Technology Co., Ltd. based, and how does that affect its regulatory standing?
Dentmate Technology Co., Ltd. is based in the United States, which means its devices are subject to FDA regulations. The company’s products are classified under the FDA’s 510(k) premarket notification process and the Unique Device Identification (UDI) system, ensuring traceability and compliance with U.S. medical device standards. The FDA categorizes these devices as Class I or Class II, depending on their risk level and intended use.
Which regulatory registries or databases list Dentmate Technology Co., Ltd.’s devices?
Dentmate Technology Co., Ltd.’s devices are included in the FDA’s 510(k) database and the FDA’s UDI system, which tracks medical devices through unique identifiers. These registries help ensure transparency in device approvals, compliance, and post-market monitoring. The inclusion in these systems confirms that the devices meet FDA requirements for safety and effectiveness before entering the market.
How are Dentmate Technology Co., Ltd.’s devices classified under FDA regulations?
The FDA classifies Dentmate Technology Co., Ltd.’s devices into Class I or Class II based on their risk level and intended use. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and performance. The classification determines the regulatory pathway, such as the 510(k) premarket submission, ensuring the devices meet necessary standards before commercialization.
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
- 656134660
Catalogue (42)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ledex | WL-120 | FDA UDI | Class II | Active |
| Ledex | WL-070+ (ORTHO) | FDA UDI | Class II | Active |
| Ledex | WL-070+ (ORTHO) | FDA UDI | Class II | Active |
| Ledex | WL-070+ | FDA UDI | Class II | Active |
| Ledex | WL-070+ (ORTHO) | FDA UDI | Class II | Active |
| Ledex | WL-070 | FDA UDI | Class II | Active |
| Ledex | WL-070+ (ORTHO) | FDA UDI | Class II | Active |
| Ledex | WL-070 | FDA UDI | Class II | Active |
| Lumindex | LUMINDEX 5 | FDA UDI | Class I | Active |
| Ledex | WL-070 | FDA UDI | Class II | Active |
| Ledex | WL-070+ (ORTHO) | FDA UDI | Class II | Active |
| Ledex | WL-070+ | FDA UDI | Class II | Active |
| Ledex | WL-070+ (ORTHO) | FDA UDI | Class II | Active |
| Ledex | WL-070 | FDA UDI | Class II | Active |
| Ledex | WL-070 | FDA UDI | Class II | Active |
| Ledex | WL-120 | FDA UDI | Class II | Active |
| Ledex | WL-070+ (ORTHO) | FDA UDI | Class II | Active |
| Ledex | WL-070+ | FDA UDI | Class II | Active |
| Ledex | WL-070+ (ORTHO) | FDA UDI | Class II | Active |
| Ledex | WL-090+ | FDA UDI | Class II | Active |
| Ledex | WL-070 | FDA UDI | Class II | Active |
| Ledex | WL-070+ | FDA UDI | Class II | Active |
| Ledex | WL-070+ (ORTHO) | FDA UDI | Class II | Active |
| Ledex | WL-070+ (ORTHO) | FDA UDI | Class II | Active |
| Ledex | WL-070+ (ORTHO) | FDA UDI | Class II | Active |
| Ledex | WL-070+ | FDA UDI | Class II | Active |
| Ledex | WL-070 | FDA UDI | Class II | Active |
| Ledex | WL-070+ (ORTHO) | FDA UDI | Class II | Active |
| Ledex | WL-070 | FDA UDI | Class II | Active |
| Ledex | WL-070+ (ORTHO) | FDA UDI | Class II | Active |
| Ledex | WL-070+ (ORTHO) | FDA UDI | Class II | Active |
| Ledex | WL-090 | FDA UDI | Class II | Active |
| Lumindex | LUMINDEX 3 | FDA UDI | Class I | Active |
| Ledex | WL-070 | FDA UDI | Class II | Active |
| Lumindex | LUMINDEX 3 | FDA UDI | Class I | Active |
| Ledex | WL-070+ | FDA UDI | Class II | Active |
| Lumindex | LUMINDEX 3 | FDA UDI | Class I | Active |
| Ledex | WL-070+ | FDA UDI | Class II | Active |
| Ledex, Model: Wl-070 | K082408 | FDA 510(k) | Class II | Active |
| Ledex Wl070+ | K163605 | FDA 510(k) | Class II | Active |
| Ledex | K131042 | FDA 510(k) | Class II | Active |
| Ledex | K221194 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Dentmate Technology Co., Ltd. New Taipei · TW FEI 3007662989