Shanghai Smedent Medical Instrument Co., Ltd.
Registered establishment in Shanghai, China. 30 device types.
Shanghai Smedent Medical Instrument Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Bur, Dental, Cotton, Roll and 28 other device types. Its earliest product listing with the FDA dates from 2016.
Registration
| Registered name | SHANGHAI SMEDENT MEDICAL INSTRUMENT CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008370577 |
| FEI number | 3008370577 |
| Establishment type | Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Suite 310, 10th Building, |
| Postal code | 201101 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorber, Saliva, Paper | Class 1 | dental bibs, safe gauze ,non-woven gauze | 2024 | 86 |
| Alloy, Metal, Base | Class 2 | Welding Wire, Welding Rod, Metal Powder, Alloy Powder , Co-Cr discs ,Titanium Discs | 2024 | 24 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Wood & Cotton tip applicators, Plastic & Cotton applicators | 2024 | 186 |
| Applicator, Resin | Class 1 | applicator, resin – dental applicators, mixing pad; mixing well; brush handle, brush tips; | 2024 | 24 |
| Broach, Endodontic | Class 1 | starryshine | 2016 | 10 |
| Bur, Dental | Class 1 | Dental Diamond burs Dental Carbide burs | 2016 | 46 |
| Carver, Dental Amalgam, Operative | Class 1 | Disposable Traps, Plastic Retainer Denture, Cuspidor Strainer | 2025 | 5 |
| Chair, Dental, Without Operative Unit | Class 1 | paper tray cover | 2024 | 38 |
| Cotton, Roll | Class 1 | cotton roll | 2024 | 107 |
| Cup, Prophylaxis | Class 1 | prophy angle ,prophy brush, prophy cup, prophy point | 2024 | 49 |
| Dispenser, Liquid Medication | Class 1 | poly coated paper cup ,plastic cup | 2024 | 86 |
| File, Pulp Canal, Endodontic | Class 1 | Starryshine | 2016 | 53 |
| Gutta-Percha | Class 1 | Starryshine | 2016 | 42 |
| Holder, Film, X-Ray | Class 1 | Plastic Film Holder, Bite Block, Barrier Envelope, Sensor Holder, Film Mount | 2025 | 40 |
| Instrument, Hand, Calculus Removal | Class 1 | Polishing cup , polishing stone ,mounted stone, polishing point | 2024 | 13 |
| Instrument, Manual, Surgical, General Use | Class 1 | Denture box, retainer box | 2024 | 110 |
| Instruments, Dental Hand | Class 1 | dental wedges ,matrix band, bib clips, bite wing arm, Dappen dishes, spatulas, bite block, hand instruments | 2024 | 64 |
| Mouthpiece, Saliva Ejector | Class 1 | Product: DYN – Mouthpiece, saliva ejector, saliva ejector tips, evacuator tips, aspirator tips | 2024 | 68 |
| Non-Surgical Gown | Class 1 | Isolation gowns ,Surgical gowns, Isolation gowns ,lab gowns ,surgical gowns | 2024 | 318 |
| Paper, Articulation | Class 1 | Dental Articulating Paper | 2016 | 12 |
| Plugger, Root Canal, Endodontic | Class 1 | Starryshine | 2016 | 19 |
| Point, Paper, Endodontic | Class 1 | Starryshine | 2016 | 35 |
| Reamer, Pulp Canal, Endodontic | Class 1 | Starryshine | 2016 | 10 |
| Spreader, Pulp Canal Filling Material, Endodontic | Class 1 | Starryshine | 2016 | 17 |
| Syringe, Periodontic, Endodontic, Irrigating | Class 1 | Curved Utility Syringe, Syringe, pre-bent needle tips ,Endodontic Irrigation Syringe | 2024 | 32 |
| Toothbrush, Manual | Class 1 | 2023 | 244 | |
| Tray, Impression, Preformed | Class 1 | Impression tray performed, paper tray cover | 2024 | 73 |
| Tubing, Noninvasive | Class 2 | Rubber Latex AND PVC Tubing,evacupak; Multiple Noninvasive Tubings; Pleur-Evac | 2024 | 33 |
| Unit, Operative Dental, Accessories | Class 1 | air water syringe sleeve, plastic tray sleeve, full/half chair sleeve, headrest cover , barrier films | 2023 | 65 |
| Unit, Syringe, Air And/Or Water | Class 1 | air water syringe tips plastic w/Metal core, metal air water syringe tips metal | 2024 | 56 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Main products | dental burs, steam sterilizers, dental laboratory equipment, rotating tools, dental consumables |
| Certifications | CE, ISO, FDA |
| Export markets | 120+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
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.