# Premium Plus International Limited

- Location (FDA's records): Hong Kong, CN
- FDA decisions: 4 (2010–2017): 4 510(k) clearances
- Product codes: EFB (1), PEM (1), EGS (1), EBZ (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dentalez, Inc.: 1 (https://510kreport.com/company/dentalez)
- Pac-Dent International, Inc.: 1 (https://510kreport.com/company/pac-dent-international)
- Dentmate Technology Co., Ltd.: 1 (https://510kreport.com/company/dentmate-technology)
- Coltene/Whaledent, Inc.: 1 (https://510kreport.com/company/coltene-whaledent)

## Firms that cite its devices most
- Premium Plus (Dongguan) Limited: 2 (https://510kreport.com/company/premium-plus-dongguan)
- Air Techniques, Inc.: 1 (https://510kreport.com/company/air-techniques)

## Its most-cited devices
- K163447: Premium Plus Disposable Barrier Sleeve (2017), cited by 1
- K100854: Premium Plus Disposable Prophy Angle Model 3399 (2010), cited by 1
- K153514: Premium Plus C01/C02 LED Curing Light (2016), cited by 1

## Recent decisions
- K170261: Premium Plus Prophy Air Motor (Oct 19, 2017)
- K163447: Premium Plus Disposable Barrier Sleeve (Jun 20, 2017)
- K153514: Premium Plus C01/C02 LED Curing Light (Aug 22, 2016)
- K100854: Premium Plus Disposable Prophy Angle Model 3399 (Dec 9, 2010)

Source page: https://510kreport.com/company/premium-plus-international