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Sign in to claim this brandUnited Dental Changzhou
US
Last updated May 23, 2026
What United Dental Changzhou makes
United Dental Changzhou manufactures reusable rotary and manual endodontic files and rasps, designed for root canal preparation in dental procedures. Their product line includes a single device type, Bondent, which is used in endodontic treatments to clean and shape the interior of teeth.
The company’s products fall under Class I medical devices and are listed in the FDA’s Unique Device Identification (UDI) system. United Dental Changzhou operates from the United States, adhering to regulatory requirements for 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 United Dental Changzhou manufacture?
United Dental Changzhou specializes in reusable endodontic files and rasps, which are tools used in root canal treatments. These devices are designed for cleaning and shaping the interior of teeth during dental procedures. The company’s product line includes rotary/reciprocating and manual versions, all branded under the Bondent name.
Where is United Dental Changzhou based, and what regulatory framework does it follow?
United Dental Changzhou is based in the United States. As a manufacturer of medical devices, it must comply with U.S. regulatory requirements, including those for dental instruments. The company’s products are listed in the FDA’s Unique Device Identification (UDI) system, which helps track and monitor medical devices in the market.
How are United Dental Changzhou’s devices classified under U.S. regulations?
United Dental Changzhou’s devices fall under Class I classification in the U.S. regulatory system. This classification applies to low-risk medical devices, such as reusable endodontic files and rasps, which are generally considered safe and effective for their intended use without stringent pre-market approval processes beyond registration and listing requirements.
Are United Dental Changzhou’s devices listed in any regulatory registries?
Yes, United Dental Changzhou’s devices are included in the FDA’s Unique Device Identification (UDI) system. This registry helps ensure traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to identify and verify the devices in use.
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
- 543963705
Catalogue (166)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bondent | V2 | FDA UDI | Class I | Active |
| Bondent | Stainless Steel K Files | FDA UDI | Class I | Active |
| Bondent | V1 | FDA UDI | Class I | Active |
| Bondent | Stainless Steel K Files | FDA UDI | Class I | Active |
| Bondent | V2 | FDA UDI | Class I | Active |
| Bondent | Stainless Steel K Files | FDA UDI | Class I | Active |
| Bondent | V2 | FDA UDI | Class I | Active |
| Bondent | Stainless Steel K Files | FDA UDI | Class I | Active |
| Bondent | Stainless Steel K Files | FDA UDI | Class I | Active |
| Bondent | Stainless Steel K Files | FDA UDI | Class I | Active |
| Bondent | V1 | FDA UDI | Class I | Active |
| Bondent | M3-Immature Blue | FDA UDI | Class I | Active |
| Bondent | V2 | FDA UDI | Class I | Active |
| Bondent | UDG-Platinum V.EU | FDA UDI | Class I | Active |
| Bondent | V1 | FDA UDI | Class I | Active |
| Bondent | Stainless Steel K Files | FDA UDI | Class I | Active |
| Bondent | V2 | FDA UDI | Class I | Active |
| Bondent | Stainless Steel K Files | FDA UDI | Class I | Active |
| Bondent | V2 | FDA UDI | Class I | Active |
| Bondent | V1 | FDA UDI | Class I | Active |
| Bondent | Stainless Steel K Files | FDA UDI | Class I | Active |
| Bondent | M3-Immature Blue | FDA UDI | Class I | Active |
| Bondent | UDG-Platinum V.EU | FDA UDI | Class I | Active |
| Bondent | V1 | FDA UDI | Class I | Active |
| Bondent | V2 | FDA UDI | Class I | Active |
| Bondent | Stainless Steel K Files | FDA UDI | Class I | Active |
| Bondent | UDG-Platinum V.EU | FDA UDI | Class I | Active |
| Bondent | V1 | FDA UDI | Class I | Active |
| Bondent | V1 | FDA UDI | Class I | Active |
| Bondent | V2 | FDA UDI | Class I | Active |
| Bondent | UDG-Flash | FDA UDI | Class I | Active |
| Bondent | UDG-Platinum V.EU | FDA UDI | Class I | Active |
| Bondent | Stainless Steel C Files | FDA UDI | Class I | Active |
| Bondent | Stainless Steel C Files | FDA UDI | Class I | Active |
| Bondent | V2 | FDA UDI | Class I | Active |
| Bondent | Stainless Steel K Files | FDA UDI | Class I | Active |
| Bondent | V2 | FDA UDI | Class I | Active |
| Bondent | Stainless Steel K Files | FDA UDI | Class I | Active |
| Bondent | V2 | FDA UDI | Class I | Active |
| Bondent | V1 | FDA UDI | Class I | Active |
| Bondent | Stainless Steel K Files | FDA UDI | Class I | Active |
| Bondent | Stainless Steel C Files | FDA UDI | Class I | Active |
| Bondent | Stainless Steel K Files | FDA UDI | Class I | Active |
| Bondent | M3-Immature Blue | FDA UDI | Class I | Active |
| Bondent | UDG-Platinum V.EU | FDA UDI | Class I | Active |
| Bondent | Stainless Steel K Files | FDA UDI | Class I | Active |
| Bondent | Stainless Steel K Files | FDA UDI | Class I | Active |
| Bondent | V1 | FDA UDI | Class I | Active |
| Bondent | M3-Immature Blue | FDA UDI | Class I | Active |
| Bondent | UDG-Platinum V.EU | FDA UDI | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- United Dental Changzhou Changzhou Jiangsu · CN FEI 3015526995