Premium Plus International Limited
Hong Kong, HK
Premium Plus International Limited appears in FDA device records in Hong Kong, HK. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Premium Plus International Limited between 2010 and 2017. The busiest year on record is 2017, with 2. The most recent is 2017, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K170261 | Premium Plus Prophy Air Motor | EFB | Substantially Equivalent | |
| K163447 | Premium Plus Disposable Barrier Sleeve | PEM | Substantially Equivalent | |
| K153514 | Premium Plus C01/C02 LED Curing Light | EBZ | Substantially Equivalent | |
| K100854 | PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 | EGS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006847937 | 3006847937 | Premium Plus International Limited | Flat 1001 Yuen Long Trading Centre, 33, Hong Kong None HK | 2026 | and 18 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHRAbsorber, Saliva, Paper
- LYUAccessory, Surgical Apparel
- EBZActivator, Ultraviolet, For Polymerization
- EJRAgent, Polishing, Abrasive, Oral Cavity
- GEACannula, Surgical, General & Plastic Surgery
- NNIContainer, Specimen, Non-Sterile
- EFNCotton, Roll
- EHKCup, Prophylaxis
- PEMDental Barriers And Sleeves
- NABGauze / Sponge,Nonresorbable For External Use
- EJBHandle, Instrument, Dental
- EFBHandpiece, Air-Powered, Dental
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental
- MDMInstrument, Manual, Surgical, General Use
- EAXMirror, Mouth
- JDZMixer, Cement, For Clinical Use
- DYNMouthpiece, Saliva Ejector
- EIGRetractor, All Types
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- FZMStool, Operating-Room
- EHMStrip, Polishing Agent
- EIDSyringe, Restorative And Impression Material
- EFWToothbrush, Manual
- KMTTray, Fluoride, Disposable
- EHYTray, Impression, Preformed
- FSMTray, Surgical, Instrument
- NRDUnit, Operative Dental, Accessories
- FRGWrap, Sterilization
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain