Skip to the page
Get started free

Data / Medical devices / China / Premium Plus (dongguan) Limited

Premium Plus (dongguan) Limited: FDA-registered device maker in Dongguan Guangdong, China, 4 510(k) clearances

Premium Plus (dongguan) Limited is registered with the FDA (registration 3027234828) in Dongguan Guangdong, China. It lists 34 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 15, 2025. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Premium Plus (dongguan) Limited
FDA registration number
3027234828
Address
Flat 101, No.122, Tianqiao Road, Changping, Dongguan Guangdong, China, 523581
Owner or operator
Premium Plus (Dongguan) Limited (10092177)
Roles
Manufacturer, Repackager or relabeler
First device listed
December 11, 2024
Registered through
2027
Brand names listed
Activator, for polymerization, Dental Curing Light, Applicator tips, Barrier sleevese, barrier envelopes, Bite Block Sleeves, Brush applicator, brush tips, applicators, Bur brush, brass/stainess steel wire brushes, aspirator brush, Bur tray, Bur dispenser, Bur Block, Bur Stand, Endo Holder, Endo Organizer Box, Chair Sleeves and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Manufactureraccessdata.fda.gov
Activator, Ultraviolet, For PolymerizationEBZ2Manufactureraccessdata.fda.gov
Applicator, ResinKXR1Manufactureraccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Manufactureraccessdata.fda.gov
Chair, Dental, Without Operative UnitNRU1Manufactureraccessdata.fda.gov
Cup, ProphylaxisEHK1Manufactureraccessdata.fda.gov
Dental Barriers And SleevesPEM2Manufactureraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Manufactureraccessdata.fda.gov
Frame, Rubber DamEJE1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
Handle, Instrument, DentalEJB1Manufactureraccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Manufactureraccessdata.fda.gov
Holder, Film, X-RayEGZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufactureraccessdata.fda.gov
Instruments, Dental HandDZN1Manufactureraccessdata.fda.gov
Mirror, MouthEAX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Manufactureraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Manufactureraccessdata.fda.gov
Needle, DentalDZM1Manufactureraccessdata.fda.gov
Retractor, All TypesEIG1Manufactureraccessdata.fda.gov
Scraper, TongueLCN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Manufactureraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Manufactureraccessdata.fda.gov
Toothbrush, ManualEFW1Manufactureraccessdata.fda.gov
Tray, Fluoride, DisposableKMT1Manufactureraccessdata.fda.gov
Tray, Impression, PreformedEHY1Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Manufactureraccessdata.fda.gov
Wrap, SterilizationFRG2Repackager or relabeleraccessdata.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
September 15, 2025K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)EGSSubstantially EquivalentPremium Plus (Dongguan) Limitedaccessdata.fda.gov
April 10, 2025K250009LED Curing Light (C01-X, C02-X)EBZSubstantially EquivalentPremium Plus (Dongguan) Limitedaccessdata.fda.gov
May 11, 2022K220662Disposable Barrier SleevesPEMSubstantially EquivalentPremium Plus (Dongguan) Limitedaccessdata.fda.gov
April 28, 2017K162258Self Sealing Sterilization PouchesFRGSubstantially EquivalentTianchang Jiarui Packaging Material Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated September 15, 2025. 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.