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Data / Medical devices / China / Tribest Dental Products Co Ltd

Tribest Dental Products Co Ltd: FDA-registered device maker in Yangzhong Jiangsu, China, 2 510(k) clearances

Tribest Dental Products Co Ltd is registered with the FDA (registration 3008887731) in Yangzhong Jiangsu, China. It lists 58 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 24, 2019. Registered through 2026. FDA data exported November 3, 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.

FDA registration number
3008887731
Address
No.98 Zhongling Road,Sanmao Street, Yangzhong Jiangsu, China, 212101
Owner or operator
TRIBEST DENTAL PRODUCTS CO LTD (10035953)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
April 6, 2011
Registered through
2026
Brand names listed
Air-water syringe tip (metal & plastic), Surgical tip Air-water syringe, tip cover, High volume evacuator, Bite tray, Brush applicator, Brush applicator with handle, COMPOSITE GUN, COTTON BALL, COVER, SHOE, OPERATING-ROOM, Cheek retractor and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Manufactureraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Manufactureraccessdata.fda.gov
Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)KOQ1Exporter to the USaccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Exporter to the US, Manufactureraccessdata.fda.gov
Aid, TransferIKX1Exporter to the US, Manufactureraccessdata.fda.gov
Aligner, Bracket, OrthodonticECQ1Manufactureraccessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Manufactureraccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Exporter 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, Saw, General & Plastic Surgery, SurgicalGFA1Exporter to the US, Manufactureraccessdata.fda.gov
Blender/MixerJRO1Exporter to the US, Manufactureraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Exporter to the US, Manufactureraccessdata.fda.gov
Bur, DentalEJL1Exporter to the US, Manufactureraccessdata.fda.gov
Bur, Ear, Nose And ThroatEQJ1Exporter to the US, Manufactureraccessdata.fda.gov
Cap, SurgicalFYF1Manufactureraccessdata.fda.gov
Capsule, Dental, AmalgamDZS1Exporter to the US, Manufactureraccessdata.fda.gov
Chair, Examination And TreatmentFRK1Manufactureraccessdata.fda.gov
Cleaner, Denture, MechanicalJER1Manufactureraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Manufactureraccessdata.fda.gov
Cotton, RollEFN1Exporter to the US, Manufactureraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Manufactureraccessdata.fda.gov
Cup, ProphylaxisEHK1Exporter to the US, Manufactureraccessdata.fda.gov
Endoscopic Bite BlockMNK1Exporter 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
Floss, DentalJES1Manufactureraccessdata.fda.gov
Forceps, Dressing, DentalEFL1Exporter to the US, Manufactureraccessdata.fda.gov
Frame, SpectacleHQZ1Manufactureraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the US, Manufactureraccessdata.fda.gov
Gutta-PerchaEKM1Exporter to the US, Manufactureraccessdata.fda.gov
Handle, Instrument, DentalEJB1Exporter to the US, Manufactureraccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Exporter to the USaccessdata.fda.gov
Holder, Film, X-RayEGZ1Manufactureraccessdata.fda.gov
Instrument, Contouring, Matrix, OperativeEKF1Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Exporter to the US, Manufactureraccessdata.fda.gov
Instruments, Dental HandDZN1Manufactureraccessdata.fda.gov
Magnifier, Hand-Held, Low-VisionHJF1Exporter to the US, Manufactureraccessdata.fda.gov
Mask, ScavengingKHA1Manufactureraccessdata.fda.gov
Mask, SurgicalFXX2Repackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Exporter to the US, Manufactureraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Manufactureraccessdata.fda.gov
Needle, DentalDZM1Exporter to the US, Manufactureraccessdata.fda.gov
Non-Surgical GownOEA1Manufactureraccessdata.fda.gov
Point, Paper, EndodonticEKN1Exporter to the US, Manufactureraccessdata.fda.gov
Probe, PeriodonticEIX1Exporter to the US, Manufactureraccessdata.fda.gov
Retractor, All TypesEIG1Exporter to the US, Manufactureraccessdata.fda.gov
Support, Patient PositionCCX1Exporter 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
Toothbrush, ManualEFW1Exporter to the US, Manufactureraccessdata.fda.gov
Tray, Impression, PreformedEHY1Exporter 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
Wax, Dental, IntraoralEGD1Exporter to the USaccessdata.fda.gov
Wrap, SterilizationFRG2Contract 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
January 24, 2019K182514Surgical Face MaskFXXSubstantially EquivalentXiantao Zhibo Non-Woven Products Co., Ltd.accessdata.fda.gov
December 9, 2010K100854PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399EGSSubstantially EquivalentPremium Plus International Limitedaccessdata.fda.gov

Compare with other makers

Updated January 24, 2019. 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.