Tribest Dental Products Co Ltd
Registered establishment in Yangzhong, Jiangsu, China. 58 device types.
Tribest Dental Products Co Ltd is a contract manufacturer holding a current FDA establishment registration. The registration covers Bur, Dental, Cotton, Roll and 56 other device types. Its earliest product listing with the FDA dates from 2011.
Registration
| Registered name | TRIBEST DENTAL PRODUCTS CO LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008887731 |
| FEI number | 3008887731 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 镇江健而乐牙科器材有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Yangzhong |
|---|---|
| Province | Jiangsu |
| Address | No.98 Zhongling Road,Sanmao Street |
| Postal code | 212101 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorber, Saliva, Paper | Class 1 | 2011 | 86 | |
| Accessory, Surgical Apparel | Class 1 | 2011 | 439 | |
| Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) | Class 1 | 2018 | 4 | |
| Agent, Polishing, Abrasive, Oral Cavity | Class 1 | 2017 | 25 | |
| Aid, Transfer | Class 1 | Retainer Box,retainer Case,denture BOX | 2023 | 118 |
| Aligner, Bracket, Orthodontic | Class 1 | Chewies | 2022 | 30 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | 2011 | 58 | |
| Applicator, Absorbent Tipped, Sterile | Class 1 | Cotton tipped applicator | 2011 | 100 |
| Applicator, Resin | Class 1 | Micro Brush Applicator | 2013 | 24 |
| Band, Elastic, Orthodontic | Class 1 | Polishing brush,Elastance chain,Ligature tie,Orthodontic Bracket,tooth model,Orthodontic kit, Orthodontic arch wire,Orthodontic band,Orthodontic buccal tube, Separator elastormeric,probe (forceps),Orthodontic elastic | 2011 | 36 |
| Bedding, Disposable, Medical | Class 1 | 2013 | 308 | |
| Blade, Saw, General & Plastic Surgery, Surgical | Class 1 | 2013 | 25 | |
| Blender/Mixer | Class 1 | 2016 | 7 | |
| Bracket, Metal, Orthodontic | Class 1 | Orthodontic KIT | 2023 | 52 |
| Bur, Dental | Class 1 | 2013 | 46 | |
| Bur, Ear, Nose And Throat | Class 1 | Plastic bur holder | 2011 | 5 |
| Cap, Surgical | Class 1 | 2011 | 178 | |
| Capsule, Dental, Amalgam | Class 1 | 2013 | 2 | |
| Chair, Examination And Treatment | Class 1 | 2011 | 23 | |
| Cleaner, Denture, Mechanical | Class 1 | 2011 | 12 | |
| Cleaner, Ultrasonic, Medical Instrument | Class 1 | 2011 | 48 | |
| Cotton, Roll | Class 1 | Cotton Ball | 2011 | 107 |
| Cover, Shoe, Operating-Room | Class 1 | Cover, Shoe, Operating-Room | 2011 | 176 |
| Cup, Prophylaxis | Class 1 | Dappen dish,glass,plastic Glass mortar & pestle Alcohol lamp No-stick mixing cup | 2011 | 49 |
| Endoscopic Bite Block | Class 1 | 2016 | 44 | |
| Evacuator, Oral Cavity | Class 1 | Air-water syringe tip (metal & plastic), Surgical tip Air-water syringe, tip cover, High volume evacuator | 2011 | 49 |
| File, Pulp Canal, Endodontic | Class 1 | Endodontic Pulp Canal File | 2015 | 53 |
| Floss, Dental | Class 1 | 2011 | 151 | |
| Forceps, Dressing, Dental | Class 1 | Disposable dental kit, Disposable dental tweezer | 2011 | 22 |
| Frame, Spectacle | Class 1 | 2011 | 430 | |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Dental Occluding Paper, ALCOHOL PREP PAD, Dental tray paper cover, Mixing bowl & spatula, Cotton gauze, Mixing pad spatula, Non-woven gauze, Mixing pad, Stirring rod | 2011 | 266 |
| Gutta-Percha | Class 1 | Gutta-Percha Point,absorbent Paper Points | 2015 | 42 |
| Handle, Instrument, Dental | Class 1 | 2013 | 29 | |
| Handpiece, Contra- And Right-Angle Attachment, Dental | Class 1 | 2018 | 9 | |
| Holder, Film, X-Ray | Class 1 | Film positioning system complete | 2022 | 40 |
| Instrument, Contouring, Matrix, Operative | Class 1 | Tofflemire matrix bands | 2022 | 10 |
| Instrument, Manual, Surgical, General Use | Class 1 | Dental bib dispenser, Retainer box, Face mask dispenser, Cotton roll dispenser, Denture box | 2011 | 110 |
| Instruments, Dental Hand | Class 1 | 2011 | 64 | |
| Magnifier, Hand-Held, Low-Vision | Class 1 | 2011 | 22 | |
| Mask, Scavenging | Class 1 | 2011 | 158 | |
| Mask, Surgical | Class 2 | 2021 | 125 | |
| Mirror, Mouth | Class 1 | Disposable dental mirror | 2011 | 94 |
| Mouthpiece, Saliva Ejector | Class 1 | 2011 | 68 | |
| Needle, Dental | Class 1 | Pre-bent needle tip, Dispensing tip | 2011 | 56 |
| Non-Surgical Gown | Class 1 | 2011 | 318 | |
| Point, Paper, Endodontic | Class 1 | Endodontic File | 2015 | 35 |
| Probe, Periodontic | Class 1 | Disposable dental probe | 2011 | 34 |
| Retractor, All Types | Class 1 | Cheek retractor | 2011 | 45 |
| Support, Patient Position | Class 1 | 2016 | 66 | |
| Syringe, Periodontic, Endodontic, Irrigating | Class 1 | Disposable dental syringe | 2011 | 32 |
| Syringe, Restorative And Impression Material | Class 1 | Mixing TIP, Composite GUN | 2012 | 49 |
| Tape And Bandage, Adhesive | Class 1 | 2016 | 353 | |
| Toothbrush, Manual | Class 1 | Dental Brush, Micro applicator, Brush applicator with handle, Brush applicator | 2011 | 244 |
| Tray, Impression, Preformed | Class 1 | Dental Tray, Bite tray, Plastic Tray | 2011 | 73 |
| Tray, Surgical, Instrument | Class 1 | Disinfection Container (BOX) | 2012 | 105 |
| Unit, Operative Dental, Accessories | Class 1 | Disposable cups, Universal barrier film, Universal barrier film dispenser | 2011 | 65 |
| Wax, Dental, Intraoral | Class 1 | Wax,dental,intraoral | 2019 | 55 |
| Wrap, Sterilization | Class 2 | Wrap,Sterilization pouch,Sterilization reel | 2019 | 38 |
Clearances
No clearance names Tribest Dental Products Co Ltd as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K182514 | 2019-01-24 | FXX | Traditional | Xiantao Zhibo Non-Woven Products Co., Ltd. |
| K100854 | 2010-12-09 | EGS | Traditional | Premium Plus International Limited |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Main products | Face masks, Dental bibs, Impression trays, Sterilization pouches, Orthodontic products |
| Certifications | CE, ISO 13485, FDA |
| Export markets | Germany, Turkey, China, South Korea, Global |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Jiangsu Reak Healthy Articles Co., Ltd. | 18 |
| Jiangsu Xiangyu Fitness Equipment Co., Ltd. | 12 |
| Yangzhong Meidi Medical Products Co., Ltd. | 3 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.