Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006847937

FEI Number

3006847937

Entity Name

Premium Plus International Limited

City/State/Country

Hong Kong, HK

Establishment Address

Flat 1001 Yuen Long Trading Centre, 33, Wang Yip Street West, Yuen Long N.T., Hong Kong None, HK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Premium Plus International Limited (Owner Number: 10023657)

Owner / Operator Contact Address

Flat 1001 Yuen Long Trading Centre, 33, Wang Yip Street West, Yuen Long, N.T., Hong Kong, HK-NOTA None, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Dentmas 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 , Dentmas 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 Dentmas Disposable Saliva Ejectors Dentmas Atomo Dental Disposable Prophy Angle Dentmas 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, Dentmas 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 Dentmas DISPOSABLE EYE SHIELDS PREMIUM PLUS Dentmas PREMIUM HAND INSTRUMENTS Prophy Paste Cup Medium, Fine and Cup Holder Finishing Strips single/double size coated Impression Trays Dentmas

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2007-12-08
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2011-08-12
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2010-04-09
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2017-06-27
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2011-01-19
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2011-01-19
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2011-01-19
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2007-12-08
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2007-12-08
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2011-01-19
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2017-10-30
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2011-01-19
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2010-12-09
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2011-01-19
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2007-12-08
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2011-01-19
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2010-12-09
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2025-12-19
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2025-12-19
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2007-12-08

Official Correspondent

Chris Tsang

US Agent Details

W M Mak Business: Premium Plus Dental Supplies Inc. Email: info@premiumplususa.com Phone: (718) 3668686

Related Public Records

Same Entity

Premium Plus International Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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3012312751	DENTAL BRANDS FOR LESS	Markham Ontario, CA
3004130302	MICERIUM S.P.A.	AVEGNO Genova, IT
3014926389	Jiangsu JianYu Health Medical Co., Ltd	Changzhou City Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006847937. Last updated year: 2026. Please use registration number 3006847937 when referencing this establishment in official correspondence.