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Data / Medical devices / China / Hubei Guarddent Medical Technology Co.,ltd

Hubei Guarddent Medical Technology Co.,ltd: FDA-registered device maker in Wuhan Hubei, China, 4 510(k) clearances

Hubei Guarddent Medical Technology Co.,ltd is registered with the FDA (registration 3017910185) in Wuhan Hubei, China. It lists 60 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 9, 2024. Registered through 2026. 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 Hubei Guarddent Medical Technology Co.,ltd
FDA registration number
3017910185
Address
Room 24-29th, 2/F, No. 11 Block, No.1 Guiyuan Temple South Road, Hanyang District, Wuhan Hubei, China, 430070
Owner or operator
Hubei Guarddent Medical Technology Co.,Ltd (10078958)
Roles
Exporter to the US, Manufacturer
First device listed
November 12, 2020
Registered through
2026
Brand names listed
Absorbent paper points, Air Water Syringe Tips, Aligner Chewies, Articulating Paper, Barrier Film Dispenser, Cotton Rolls Dispenser, Barrier covers, Barrier film, Blade, Bouffant Caps and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Exporter to the US, Manufactureraccessdata.fda.gov
Accessories, Retractor, DentalEIF1Exporter to the US, Manufactureraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Exporter to the US, Manufactureraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Exporter to the US, Manufactureraccessdata.fda.gov
Applicator, ResinKXR1Exporter to the US, Manufactureraccessdata.fda.gov
Band, Elastic, OrthodonticECI1Exporter to the US, Manufactureraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the US, Manufactureraccessdata.fda.gov
Blade, ScalpelGES1Exporter to the US, Manufactureraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Exporter to the US, Manufactureraccessdata.fda.gov
Bur, DentalEJL1Manufactureraccessdata.fda.gov
Cap, SurgicalFYF1Exporter to the US, Manufactureraccessdata.fda.gov
Chair, Examination And TreatmentFRK1Exporter to the US, Manufactureraccessdata.fda.gov
Cleaner, Denture, MechanicalJER1Exporter to the US, Manufactureraccessdata.fda.gov
Cotton, RollEFN1Exporter to the US, Manufactureraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Exporter to the US, Manufactureraccessdata.fda.gov
Cup, ProphylaxisEHK1Exporter to the US, Manufactureraccessdata.fda.gov
Dam, RubberEIE1Manufactureraccessdata.fda.gov
Dental Barriers And SleevesPEM2Exporter to the USaccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Exporter to the US, Manufactureraccessdata.fda.gov
Dispenser, Solid MedicationNXB1Exporter to the US, Manufactureraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Exporter to the US, Manufactureraccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Exporter to the US, Manufactureraccessdata.fda.gov
Finger CotLZB1Exporter to the US, Manufactureraccessdata.fda.gov
Floss, DentalJES1Exporter to the US, Manufactureraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the US, Manufactureraccessdata.fda.gov
Gown, SurgicalFYA2Exporter to the USaccessdata.fda.gov
Gutta-PerchaEKM1Exporter to the US, Manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Exporter to the US, Manufactureraccessdata.fda.gov
Holder, Film, X-RayEGZ1Exporter to the US, Manufactureraccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Exporter to the US, Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Exporter to the US, Manufactureraccessdata.fda.gov
Instruments, Dental HandDZN1Exporter to the US, Manufactureraccessdata.fda.gov
Mask, SurgicalFXX2Exporter to the USaccessdata.fda.gov
Material, Impression Tray, ResinEBH1Exporter to the US, Manufactureraccessdata.fda.gov
Mirror, MouthEAX1Exporter to the US, Manufactureraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Exporter to the US, Manufactureraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Exporter to the US, Manufactureraccessdata.fda.gov
Needle, DentalDZM1Exporter to the US, Manufactureraccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the US, Manufactureraccessdata.fda.gov
Paper, ArticulationEFH1Exporter to the US, Manufactureraccessdata.fda.gov
Point, Paper, EndodonticEKN1Exporter to the US, Manufactureraccessdata.fda.gov
Post, Root CanalELR1Exporter to the US, Manufactureraccessdata.fda.gov
Protector, DentalBRW1Exporter to the US, Manufactureraccessdata.fda.gov
Pusher, Band, OrthodonticECS1Exporter to the US, Manufactureraccessdata.fda.gov
Retainer, MatrixJEP1Exporter to the US, Manufactureraccessdata.fda.gov
Retainer, SurgicalGCZ1Exporter to the US, Manufactureraccessdata.fda.gov
Retractor, All TypesEIG1Exporter to the US, Manufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Exporter to the US, Manufactureraccessdata.fda.gov
Syringe, Irrigating (Dental)EIB1Exporter to the US, Manufactureraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Exporter to the US, Manufactureraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Exporter to the US, Manufactureraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the US, Manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Exporter to the US, Manufactureraccessdata.fda.gov
Toothbrush, ManualEFW1Exporter to the US, Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Exporter to the US, Manufactureraccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Exporter to the US, Manufactureraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Exporter to the US, Manufactureraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Exporter to the US, Manufactureraccessdata.fda.gov
Wire, OrthodonticDZC1Exporter to the US, Manufactureraccessdata.fda.gov
Wrap, SterilizationFRG2Exporter to the US, Manufactureraccessdata.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
May 9, 2024K233918Dental Barrier and SleevesPEMSubstantially EquivalentYongqing Huaguan Dental Instruments Factoryaccessdata.fda.gov
January 12, 2022K212718Surgical gownsFYASubstantially EquivalentXiantao Dingcheng Non-Woven Product Co., Ltd.accessdata.fda.gov
November 16, 2021K212344Surgical MaskFXXSubstantially EquivalentXiantao Dingcheng Non-Woven Product Co., Ltd.accessdata.fda.gov
April 28, 2017K162258Self Sealing Sterilization PouchesFRGSubstantially EquivalentTianchang Jiarui Packaging Material Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated May 9, 2024. 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.