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Sign in to claim this brandDmetec.Co., Ltd.
US
Last updated May 30, 2026
What Dmetec.Co., Ltd. makes
Dmetec.Co., Ltd. manufactures dental ultrasonic surgical systems, ultrasonic dental scaling and debridement systems, and dental/surgical polymerization lamps. Example products include the smarThor, Cleanse S+, SkyLight, COMPACT S, SURGYSTAR, and SKYLIGHT LED curing light devices.
The company's devices are classified as Class II medical devices and are listed in the FDA 510(k) and FDA UDI registries. Dmetec.Co., Ltd. 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 dental devices does Dmetec.Co., Ltd. manufacture?
Dmetec.Co., Ltd. produces three main categories of dental equipment: ultrasonic surgical systems for procedures, ultrasonic scaling and debridement systems for cleaning teeth, and polymerization lamps used to cure dental materials. The listed examples—such as smarThor, Cleanse S+, and SkyLight—illustrate products within each of these categories.
Where is Dmetec.Co., Ltd. headquartered?
The company is based in the United States, as indicated by the COUNTRY field in the provided data. This location determines the regulatory framework it follows for its medical devices.
In which regulatory registries are Dmetec.Co., Ltd.'s devices listed?
All of Dmetec.Co., Ltd.'s devices appear in the FDA 510(k) and FDA UDI registries. These listings mean each device has submitted a 510(k) premarket notification and has a unique device identifier, which are required for Class II medical devices in the U.S.
How are Dmetec.Co., Ltd.'s dental devices classified under U.S. regulations?
Each device from Dmetec.Co., Ltd. falls under Class II, which is a moderate‑risk category for medical devices. This classification is explicitly stated in the DEVICE CLASSES field and aligns with the requirement for 510(k) clearance and UDI registration for such devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- dmetec.com
- —
- —
- [email protected]
- Phone
- +827047167176
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 688451769
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| smarThor | G03 | FDA UDI | Class II | Active |
| Cleanse S+ | S03 | FDA UDI | Class II | Active |
| SkyLight | L01 | FDA UDI | Class II | Active |
| Compact S | S02 | FDA UDI | Class II | Active |
| Surgystar | G01 | FDA UDI | Class II | Active |
| Cleanse S+ Ultrasonic Scaler | K060171 | FDA 510(k) | Class II | Active |
| Ultrasonic Surgery Machine | K113152 | FDA 510(k) | Class II | Active |
| Compact S, Compact S (led) | K170104 | FDA 510(k) | Class II | Active |
| Skylight Led Curing Light | K051571 | FDA 510(k) | Class II | Active |
| Ultrasonic Surgery | K121620 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Dmetec Co., Ltd Bucheon Gyeonggi · KR FEI 3005344591