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Sign in to claim this brandPremium Plus International Limited
US
Last updated May 23, 2026
What Premium Plus International Limited makes
Premium Plus International Limited manufactures single-use dental polishing cups, saliva absorbents, specimen container mailers, surgical/medical face masks, and non-sterile instrument drapes. Their reusable products include instrument trays and sterilizer/disinfector rack inserts for medical instruments, as well as dental material application tools. The company also produces reusable instrument trays designed for healthcare settings.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, all of which are listed in the FDA’s Unique Device Identifier (UDI) database. The products are intended for use in dental and surgical environments, adhering to applicable U.S. regulatory standards. 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 Premium Plus International Limited manufacture?
Premium Plus International Limited produces a range of medical devices primarily for dental and surgical use. Their portfolio includes single-use items like dental polishing cups, saliva absorbents, specimen container mailers, surgical/medical face masks, and non-sterile instrument drapes. They also manufacture reusable products such as instrument trays, sterilizer/disinfector rack inserts, and dental material application tools. These devices are designed to meet the needs of healthcare settings, ensuring functionality and compliance with relevant standards.
Where is Premium Plus International Limited based?
Premium Plus International Limited is headquartered in the United States. This location allows the company to align its manufacturing and regulatory processes with U.S. standards, ensuring compliance with applicable guidelines for medical devices.
Which regulatory registries list Premium Plus International Limited’s devices?
Premium Plus International Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices commercially distributed in the U.S., ensuring transparency and traceability for regulatory and market surveillance purposes.
How are Premium Plus International Limited’s devices classified under FDA regulations?
Premium Plus International Limited’s devices fall into two primary classification categories under FDA regulations: Class I and Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body’s interaction with it.
What distinguishes the reusable and single-use devices manufactured by Premium Plus International Limited?
Premium Plus International Limited’s reusable devices, such as instrument trays and sterilizer/disinfector rack inserts, are designed for repeated use in healthcare settings after proper cleaning, sterilization, or disinfection. In contrast, their single-use devices—like dental polishing cups, surgical masks, and non-sterile drapes—are intended for one-time use only to minimize infection risks and ensure hygiene. The distinction is based on their intended lifecycle, material composition, and regulatory requirements for safety and sterility.
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
- 668367758
Catalogue (1044)
Page 21 of 21| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Premium Plus | B-CT3399-105SG | FDA UDI | Class I | Active |
| Premium Plus | CTS3399-090SP | FDA UDI | Class I | Active |
| Premium Plus | B-WTS3399-090SG | FDA UDI | Class I | Active |
| Premium Plus | B-WT3399-105SG | FDA UDI | Class I | Active |
| Premium Plus | T220RD | FDA UDI | Class I | Active |
| Premium Plus | 657L-BK | FDA UDI | Class I | Active |
| Premium Plus | T-P222XA | FDA UDI | Class I | Active |
| Premium Plus | 2221W | FDA UDI | Class I | Active |
| Premium Plus | 301-WHITE | FDA UDI | Class I | Active |
| Premium Plus | S221PK | FDA UDI | Class I | Active |
| Premium Plus | 653-20BLUE | FDA UDI | Class I | Active |
| Premium Plus | 7501-L | FDA UDI | Class I | Active |
| Premium Plus | W3399-60WT | FDA UDI | Class I | Active |
| Premium Plus | WTS3399-60SA | FDA UDI | Class I | Active |
| Premium Plus | 460 | FDA UDI | Class I | Active |
| Premium Plus | 338C | FDA UDI | Class I | Active |
| Premium Plus | B-C3399-105SP | FDA UDI | Class I | Active |
| Premium Plus | ST001-LAV | FDA UDI | Class I | Active |
| Premium Plus | 657S-LB | FDA UDI | Class I | Active |
| Premium Plus | 653-16YL | FDA UDI | Class I | Active |
| Premium Plus | 3399-090RL | FDA UDI | Class I | Active |
| Premium Plus | 653-18BGE | FDA UDI | Class I | Active |
| Premium Plus | CT3399-60LM | FDA UDI | Class I | Active |
| Premium Plus | 601-PINK | FDA UDI | Class I | Active |
| Premium Plus | B-WS3399-105SP | FDA UDI | Class I | Active |
| Premium Plus | W3399-105SG | FDA UDI | Class I | Active |
| Premium Plus | WT3399-105RB | FDA UDI | Class I | Active |
| Premium Plus | 189-2 | FDA UDI | Class II | Active |
| Premium Plus | 2200-F4 | FDA UDI | Class I | Active |
| Premium Plus | B-3399-105RL | FDA UDI | Class I | Active |
| Premium Plus | 220-RD | FDA UDI | Class I | Active |
| Premium Plus | B-CTS3399-60LM | FDA UDI | Class I | Active |
| Premium Plus | 653-19YL | FDA UDI | Class I | Active |
| Premium Plus | P222RA | FDA UDI | Class I | Active |
| Premium Plus | 600-WHITE | FDA UDI | Class I | Active |
| Premium Plus | T220PK | FDA UDI | Class I | Active |
| Premium Plus | P222OR | FDA UDI | Class I | Active |
| Premium Plus | T221DB | FDA UDI | Class I | Active |
| Premium Plus | 653-20-SA | FDA UDI | Class I | Active |
| Pearson | 140L | FDA UDI | Class II | Active |
| Premium Plus Prophy Air Motor | K170261 | FDA 510(k) | Class I | Active |
| Premium Plus Disposable Barrier Sleeve | K163447 | FDA 510(k) | Class II | Active |
| Premium Plus C01/C02 LED Curing Light | K153514 | FDA 510(k) | Class II | Active |
| Premium Plus Disposable Prophy Angle Model 3399 | K100854 | FDA 510(k) | Class I | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Premium Plus International Limited Hong Kong · HK FEI 3006847937