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Data / Medical devices / Hong Kong / Premium Plus International Limited

Premium Plus International Limited: FDA-registered device maker in Hong Kong, Hong Kong, 5 510(k) clearances

Premium Plus International Limited is registered with the FDA (registration 3006847937) in Hong Kong, Hong Kong. It lists 28 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 19, 2017. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Premium Plus International Limited
FDA registration number
3006847937
Address
Flat 1001 Yuen Long Trading Centre, 33 Wang Yip Street West, Yuen Long N.T., Hong Kong, Hong Kong, None
Owner or operator
Premium Plus International Limited (10023657)
Roles
Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
December 8, 2007
Registered through
2026
Brand names listed
/COTTON ROLLS, 078 Curved Tip Syringes, 089 Impression Syringes, 1002-4, 18-250 Prophy Cups, Snap-On, 18-251 Prophy Cups, Screw-In, 18-M252 Prophy Cups, RA, Metal Shank, 18-P252 Prophy Cups, RA, Plastic Shank and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Manufactureraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Manufactureraccessdata.fda.gov
Activator, Ultraviolet, For PolymerizationEBZ2Manufactureraccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Manufactureraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Manufactureraccessdata.fda.gov
Cotton, RollEFN1Exporter to the USaccessdata.fda.gov
Cup, ProphylaxisEHK1Manufactureraccessdata.fda.gov
Dental Barriers And SleevesPEM2Manufactureraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Manufactureraccessdata.fda.gov
Handle, Instrument, DentalEJB1Manufactureraccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Manufactureraccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufactureraccessdata.fda.gov
Mirror, MouthEAX1Manufactureraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Manufactureraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Manufactureraccessdata.fda.gov
Retractor, All TypesEIG1Manufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Manufactureraccessdata.fda.gov
Stool, Operating-RoomFZM1Exporter to the USaccessdata.fda.gov
Strip, Polishing AgentEHM1Manufactureraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Manufactureraccessdata.fda.gov
Toothbrush, ManualEFW1Manufactureraccessdata.fda.gov
Tray, Fluoride, DisposableKMT1Repackager or relabeleraccessdata.fda.gov
Tray, Impression, PreformedEHY1Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Manufactureraccessdata.fda.gov
Wrap, SterilizationFRG2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 19, 2017K170261Premium Plus Prophy Air MotorEFBSubstantially EquivalentPremium Plus International Limitedaccessdata.fda.gov
June 20, 2017K163447Premium Plus Disposable Barrier SleevePEMSubstantially EquivalentPremium Plus International Limitedaccessdata.fda.gov
August 22, 2016K153514Premium Plus C01/C02 LED Curing LightEBZSubstantially EquivalentPremium Plus International Limitedaccessdata.fda.gov
December 9, 2010K100854PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399EGSSubstantially EquivalentPremium Plus International Limitedaccessdata.fda.gov
December 27, 2007K071886SELF SEAL STERILIZATION POUCHFRGSubstantially EquivalentShanghai Jianzhong Medical Packaging Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated October 19, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.