Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008887731

FEI Number

3008887731

Entity Name

TRIBEST DENTAL PRODUCTS CO LTD

City/State/Country

Yangzhong Jiangsu, CN

Establishment Address

No.98 Zhongling Road,Sanmao Street, Yangzhong Jiangsu 212101, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

TRIBEST DENTAL PRODUCTS CO LTD (Owner Number: 10035953)

Owner / Operator Contact Address

No.5 Lianhe Cun,Xinba Town, Yangzhong, CN-JS 212101, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tofflemire matrix bands Dappen dish,glass,plastic Glass mortar & pestle Alcohol lamp No-stick mixing cup Dental Tray Plastic Tray Bite tray Mixing bowl & spatula, Cotton gauze, Mixing pad spatula Dental Occluding Paper, ALCOHOL PREP PAD, Dental tray paper cover Non-woven gauze, Mixing pad, Stirring rod Disposable dental syringe DISINFECTION CONTAINER (BOX) COTTON BALL Film positioning system complete Disposable dental kit, Disposable dental tweezer Disposable cups Universal barrier film dispenser Universal barrier film WAX,DENTAL,INTRAORAL ENDODONTIC PULP CANAL FILE Chewies ENDODONTIC FILE COMPOSITE GUN MIXING TIP Disposable dental mirror Plastic bur holder Air-water syringe tip (metal & plastic), Surgical tip Air-water syringe, tip cover, High volume evacuator GUTTA-PERCHA POINT,ABSORBENT PAPER POINTS MICRO BRUSH APPLICATOR Brush applicator with handle Micro applicator Dental Brush Brush applicator Polishing brush,Elastance chain,Ligature tie,Orthodontic Bracket,tooth model,Orthodontic kit Separator elastormeric,probe (forceps),Orthodontic elastic Orthodontic arch wire,Orthodontic band,Orthodontic buccal tube Dispensing tip Pre-bent needle tip RETAINER BOX,RETAINER CASE,DENTURE BOX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKF	Instrument, Contouring, Matrix, Operative	Dental	Class 1	872.4565	2022-07-13
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2011-10-12
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2011-04-20
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2018-02-23
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2011-04-20
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2011-10-12
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2011-10-12
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2011-04-20
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-01-04
EFN	Cotton, Roll	Dental	Class 1	872.6050	2011-04-20
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-03-09
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2022-07-13
KOQ	Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)	Dental	Class 1	872.3410	2018-02-26
HJF	Magnifier, Hand-Held, Low-Vision	Ophthalmic	Class 1	886.5540	2011-04-06
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2011-10-12
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2011-10-12
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2019-05-04
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2015-01-25
JES	Floss, Dental	Dental	Class 1	872.6390	2011-04-06
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2022-07-13
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2015-01-25
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2012-01-04
DZS	Capsule, Dental, Amalgam	Dental	Class 1	872.3110	2013-03-05
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2017-01-02
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2011-10-12
JRO	Blender/Mixer	Clinical Chemistry	Class 1	862.2050	2016-03-09
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2011-10-12
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2011-10-12
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2011-04-06
EKM	Gutta-Percha	Dental	Class 1	872.3850	2015-01-25
FRK	Chair, Examination And Treatment	General Hospital	Class 1	880.6140	2011-04-06
KXR	Applicator, Resin	Dental	Class 1	872.3140	2013-03-05
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2011-04-20
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2013-03-05
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2011-10-12
EJL	Bur, Dental	Dental	Class 1	872.3240	2013-03-05
DZM	Needle, Dental	Dental	Class 1	872.4730	2011-10-12
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-03-10
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2011-04-06
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2023-06-20
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2011-04-20
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2011-04-06
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2011-04-20
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2016-03-09

Official Correspondent

JIAHONG ZHOU

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

TRIBEST DENTAL PRODUCTS CO LTD

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
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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.
Z-0012-2012	Biomet Microfixation, Inc.	1	Biomet Microfixation outer packaging labeled in part:"REF: SP-2411*RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN**" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008887731. Last updated year: 2026. Please use registration number 3008887731 when referencing this establishment in official correspondence.