Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027234828

FEI Number

3027234828

Entity Name

PREMIUM PLUS (DONGGUAN) LIMITED

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Flat 101, No.122, Tianqiao Road, Changping, Dongguan Guangdong 523581, CN

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Premium Plus (Dongguan) Limited (Owner Number: 10092177)

Owner / Operator Contact Address

Flat 101, No.122, Tianqiao Road, Changping, Dongguan, CN-GD 523581, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Eye shield Light shield Disposable Prophy Angles Tongue cleaners Headrest Covers Endo Rulers Endo Measuring Blocks Flowable composite and etching gel tips Applicator tips X-Ray Sensor Sleeves/ Mouth Mirror Sleeves Tubing Sleeves Chair Sleeves Flowable Composite Syringe Sleeves Impression Gun Sleeves Curing Light Sleeves, Light Guide Sleeves HVE Tube Sleeves Intraoral Camera Sleeves Handpiece Sleeves Barrier sleevese, barrier envelopes Headrest Sleeves Bite Block Sleeves Syringe/HVE Sleeves Light Handle Sleeves Keyboard Sleeves/ X-Ray Head Sleeves, PC mouse sleeves Instrument Tray Sleeves, instrument sleeves Activator, for polymerization, Dental Curing Light Face masks X-Ray Bite Cushions, Bite Wing Loops Disposable peel-n-stick sensor holders X-Ray film holder, film clips Endo sponges/cushions Micro Applicators Brush applicator, brush tips, applicators interdental brush, brush Intraoral Syringe Tips Impression syringes,curved tip syringe Saliva ejectors Disposable Prophy Cups Disposable Prophy Brushes Oral evacuators HVE Suction Tubes air-water syringe tips greenline syringe tips Hand instruments Plastic wedges Composite syringe gun, composite syringe tips organisers, dispensers, holders, retainers, denture boxes tooth fracture detector,spatula, napkin holders, instrument rings, mask extenders Dental accessories Surgical aspirator tips Sterilization pouches Rubber dam frame Impression trays, 3-IN-1 Trays Dental bibs Tray papers

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2024-12-12
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2025-09-16
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2025-09-18
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2025-09-18
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2025-09-18
DZM	Needle, Dental	Dental	Class 1	872.4730	2025-09-18
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2024-12-12
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2025-05-15
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2024-12-12
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2024-12-12
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-12-12
KXR	Applicator, Resin	Dental	Class 1	872.3140	2025-09-18
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2024-12-12
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2024-12-12
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2024-12-12
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2024-12-12
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2024-12-11
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2025-09-16
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2024-12-12
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2025-09-18
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2024-12-12
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-12-12
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2024-12-12
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-12-12
EJE	Frame, Rubber Dam	Dental	Class 1	872.6300	2024-12-12
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2024-12-12
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2024-12-12

Official Correspondent

Jessica Mao

US Agent Details

Woonming Mak Email: info@premiumplusdentalusa.com Phone: (718) 3668686

Related Public Records

Same Entity

Premium Plus (Dongguan) 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
K243921	Foshan Coxo Medical Instrument Co., Ltd.	LED Curing Lights (DB686 HALO)	2025-04-11
K033201	Apoza Enterprise Co., Ltd.	LA500 BLUE LIGHT	2003-12-02
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027234828. Last updated year: 2026. Please use registration number 3027234828 when referencing this establishment in official correspondence.