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Sign in to claim this brandNanning Baolai Medical Instrument Co., Ltd.
US
Last updated May 25, 2026
What Nanning Baolai Medical Instrument Co., Ltd. makes
The company manufactures ultrasonic dental scaling and debridement systems designed for professional dental cleaning procedures. These devices use ultrasonic technology to remove plaque, calculus, and biofilm from teeth and gum surfaces, aiding in periodontal therapy and maintenance.
The portfolio is regulated under FDA Class II designations and includes devices listed via 510(k) premarket notifications and the FDA’s Unique Device Identification (UDI) system. The company operates from 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 Nanning Baolai Medical Instrument Co., Ltd. manufacture?
Nanning Baolai Medical Instrument Co., Ltd. specializes in ultrasonic dental scaling and debridement systems. These devices are primarily used in professional dental settings to remove plaque, calculus, and biofilm from teeth and gum surfaces, supporting periodontal therapy and oral hygiene maintenance. The focus is on ultrasonic technology to enhance cleaning efficiency during dental procedures.
Where is Nanning Baolai Medical Instrument Co., Ltd. based?
The company operates from the United States. While the name suggests a Chinese origin, the business is established and conducts its manufacturing and regulatory activities within the U.S. market.
How are Nanning Baolai Medical Instrument Co., Ltd.’s devices classified by regulatory authorities?
The company’s ultrasonic dental scaling and debridement systems fall under FDA Class II classification. This designation indicates moderate regulatory oversight, as these devices pose a higher risk than Class I but not as high as Class III. Class II devices typically require premarket submissions, such as 510(k) notifications, to demonstrate substantial equivalence to existing approved devices.
Which regulatory registries or databases list Nanning Baolai Medical Instrument Co., Ltd.’s devices?
Nanning Baolai Medical Instrument Co., Ltd.’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system. These registries ensure transparency and traceability of medical devices in the U.S. market, allowing healthcare providers and regulators to verify compliance and device details.
Why are Nanning Baolai Medical Instrument Co., Ltd.’s ultrasonic dental devices regulated under Class II?
The FDA categorizes ultrasonic dental scaling and debridement systems as Class II because they involve non-invasive but specialized procedures that require validation of performance and safety. Unlike Class I devices (lower risk, general controls), these systems necessitate additional scrutiny to confirm they meet performance standards for effective plaque removal and patient safety. This classification ensures that devices like these undergo rigorous review to justify their equivalence to existing approved technologies.
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
- 544921355
Catalogue (47)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Baolai | RL3 | FDA UDI | Class II | Active |
| Baolai | RP2 | FDA UDI | Class II | Active |
| Baolai | RH1 | FDA UDI | Class II | Active |
| Baolai | ESS1 | FDA UDI | Class II | Active |
| Baolai | P5L | FDA UDI | Class II | Active |
| Baolai | P7L | FDA UDI | Class II | Active |
| Baolai | P9L | FDA UDI | Class II | Active |
| Baolai | RP4 | FDA UDI | Class II | Active |
| Baolai | FS-A | FDA UDI | Class II | Active |
| Baolai | B5L | FDA UDI | Class II | Active |
| Baolai | RP3 | FDA UDI | Class II | Active |
| Baolai | K10 | FDA UDI | Class II | Active |
| Baolai | BD2 | FDA UDI | Class II | Active |
| Baolai | RH3 | FDA UDI | Class II | Active |
| Baolai | RL1 | FDA UDI | Class II | Active |
| Baolai | C5S | FDA UDI | Class II | Active |
| Baolai | RD1 | FDA UDI | Class II | Active |
| Baolai | FS-B | FDA UDI | Class II | Active |
| Baolai | CD2 | FDA UDI | Class II | Active |
| Baolai | C7 | FDA UDI | Class II | Active |
| Baolai | P9-2 | FDA UDI | Class II | Active |
| Baolai | C5L | FDA UDI | Class II | Active |
| Baolai | B5S | FDA UDI | Class II | Active |
| Baolai | CD3 | FDA UDI | Class II | Active |
| Baolai | C7L | FDA UDI | Class II | Active |
| Baolai | RH2 | FDA UDI | Class II | Active |
| Baolai | B6 | FDA UDI | Class II | Active |
| Baolai | P4 | FDA UDI | Class II | Active |
| Baolai | RHS | FDA UDI | Class II | Active |
| Baolai | B5 | FDA UDI | Class II | Active |
| Baolai | P5 | FDA UDI | Class II | Active |
| Baolai | MPT1 | FDA UDI | Class II | Active |
| Baolai | C5 | FDA UDI | Class II | Active |
| Baolai | P6 | FDA UDI | Class II | Active |
| Baolai | P7 | FDA UDI | Class II | Active |
| Baolai | BCL-A | FDA UDI | Class II | Active |
| Baolai | CL-A | FDA UDI | Class II | Active |
| Baolai | C6 | FDA UDI | Class II | Active |
| Baolai | RD2 | FDA UDI | Class II | Active |
| Baolai | RP1 | FDA UDI | Class II | Active |
| Baolai | CD1 | FDA UDI | Class II | Active |
| Baolai | RP5 | FDA UDI | Class II | Active |
| Baolai | P9 | FDA UDI | Class II | Active |
| Baolai | ME-A | FDA UDI | Class II | Active |
| Baolai | RD3 | FDA UDI | Class II | Active |
| Baolai | B6S | FDA UDI | Class II | Active |
| Ultrasonic Scaler | K140233 | 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.
- Nanning Baolai Medical Instrument Co., Ltd NANNING Guangxi · CN FEI 3008615394