BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    Premium Plus International Limited

    Reg #: 3006847937 · FEI: 3006847937 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    96
    Establishment Types
    3
    Classifications
    28

    Registration Details

    Registration Name
    Premium Plus International Limited
    Registration Number
    3006847937
    FEI Number
    3006847937
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Flat 1001 Yuen Long Trading Centre, 33, Wang Yip Street West, Yuen Long N.T.
    City
    Hong Kong
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K163447

    Owner / Operator

    Firm Name
    Premium Plus International Limited
    Operator Number
    10023657
    Address
    Flat 1001 Yuen Long Trading Centre, 33, Wang Yip Street West, Yuen Long, N.T.
    City
    Hong Kong
    State
    HK-NOTA
    Postal Code
    None
    Country
    HK
    Correspondent
    Chris Tsang

    US Agent

    Business Name
    Premium Plus Dental Supplies Inc.
    Contact Name
    W M Mak
    Address
    155 Liberty Ave
    City
    Brooklyn
    State
    NY
    ZIP
    11212
    Country
    US
    Email
    [email protected]
    Phone
    718 3668686

    Products

    Device Name Product Code
    Cup, Prophylaxis EHK
    Gauze / Sponge,Nonresorbable For External Use NAB
    Mirror, Mouth EAX
    Dental Barriers And Sleeves PEM
    Accessory, Surgical Apparel LYU
    Instrument, Manual, Surgical, General Use MDM
    Container, Specimen, Non-Sterile NNI
    Syringe, Restorative And Impression Material EID
    Mouthpiece, Saliva Ejector DYN
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Handpiece, Air-Powered, Dental EFB
    Tray, Surgical, Instrument FSM
    Unit, Operative Dental, Accessories NRD
    Mixer, Cement, For Clinical Use JDZ
    Tray, Fluoride, Disposable KMT
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Handle, Instrument, Dental EJB
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Strip, Polishing Agent EHM
    Tray, Impression, Preformed EHY
    Stool, Operating-Room FZM
    Cannula, Surgical, General & Plastic Surgery GEA
    Cotton, Roll EFN
    Retractor, All Types EIG
    Absorber, Saliva, Paper KHR
    Toothbrush, Manual EFW
    Activator, Ultraviolet, For Polymerization EBZ
    Wrap, Sterilization FRG

    Proprietary Names

    S-251 Prophy Cups, Screw-In 18-M252 Prophy Cups, RA, Metal Shank S-M252 Prophy Cups, RA, Metal Shank T-P252 Prophy Cups, RA, Plastic Shank 18-251 Prophy Cups, Screw-In T-251 Prophy Cups, Screw-In T-M252 Prophy Cups, RA, Metal Shank 18-P252 Prophy Cups, RA, Plastic Shank 18-250 Prophy Cups, Snap-On Dentmas Endo Spongers Holder 088 Endo Spongers/Cushions Mouth mirrors, Intraoral Mirrors,mirrors Premium Plus Coiled Tubing Sleeves Premium Plus X-Ray Sensor Sleeves, Large/Medium,Small & X Small Premium Plus Straight Tubing Sleeves Premium Plus Full and Half Chair Sleeves Premium Plus Bite Block Sleeves Premium Plus Low Speed / Universal Sleeves Premium Plus PC Mouse Sleeves Premium Plus Syringe Sleeves Prenium Plus Tray Sleeves Standard 'B' / Mini Premium Plus Light Guide Sleeves, Small/Medium Premium Plus PSP X-Ray Barrier Envelopes Premium Plus X-Ray Head / Keyboard Sleeves Premium Plus ISO Tray Sleeves Premium Plus Headrest Sleeves Small /Large Premium Plus High Speed / Pen Sleeves Premium Plus X-Ray Sensor Sleeves Two Step Premium Plus HVE Suction Tube Sleeves Premium Plus Pen Type Curing Light Sleeves Premium Plus T Light Handle Sleeves Premium Plus Lab Transport Bags Premium Plus Barrier Film Clear/Blue Premium Plus T Light Handle Sleeves, U-shape Premium Plus Intraoral Camera Sleeves Premium Plus Curing Light Handle Sleeves Premium Plus Impression Gun Sleeves Premium PlusTablet Sleeves FACE MASKS PREMIUM PLUS BUR TRAY,ENDO DISPENSER PREMIUM PLUS DENTAL INSTRUMENT HOLDER,BUR BLOCK,BUR DISPENSER , ORGANIZERS,DISPENSERS,HOLDERS,RETAINER,MOUTH GUARD BOX DENTURE BATHS PREMIUM PLUS Protective Light Hand Shield Protective Light Covers Name Card Holder Grinding Box 089 Impression Syringes 078 Curved Tip Syringes Disposable Saliva Ejectors Atomo Dental Disposable Prophy Angle PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 Prophy Air Motor Premium Plus Pro-Sys Hygiene Handpiece 1002-4 CASSETTES PREMIUM PLUS PLASTIC TRAY,TRAY RACK,INSTRUMENT MATS,CABINET TRAY, Syringe Sleeves Barrier Film Handpiece Sleeves Premium Plus Barrier Sleeves Instrument Tray Sleeves Handle Sleeves Light/Sensor Sleeves/Pouches MIXING CUP,MIXING WELLS,MIXING BOWL,DAPPEN DISH,MIXING RING PREMIUM PLUS 7800 Fluoride Trays 7801 Fluoride Trays DISPOSABLE EYE SHIELDS PREMIUM PLUS PREMIUM HAND INSTRUMENTS Prophy Paste Cup Medium, Fine and Cup Holder Finishing Strips single/double size coated Impression Trays Stool Premiumplus SURGICAL ASPIRATORS TIP,ASPIRATOR BRUSH PREMIUM PLUS Cotton Rolls 2030 Intraoral Lippers 2080 Intraoral Cheek Retractor 2050A-2 Cheek Retractors 2055C-2 Cheek Retractors 2090 Mouth Props 2050C-2 Cheek Retractors 2055A-2 Cheek Retractors 2040 Intraoral Lippers 2060 Intraoral Cheek Retractor DENTAL BIBS PREMIUM PLUS /COTTON ROLLS Interproximal brushes Interdental Brushes Model C01 LED Curing Light Model C02 Soleil 770 Sterilization Wrap

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device