Manufacturer registered with FDA
Shanghai Fanta Dental Materials Co., Ltd.
Shanghai, China. Lists 13 dental device types with FDA across 1 registered establishment.
- Device types listed
- 13
- Brands and models
- 31
- 510(k) clearances
- 0as applicant
- Markets registered in
- 822 registrations outside the US
- Establishments
- 1China
Registered in 8 markets
Where regulators' registries name Shanghai Fanta Dental Materials Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Shanghai Fanta Dental Materials Co., Ltd. | 13 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Shanghai Fanta Dental Materials Co., Ltd | 6 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SHANGHAI FANTA DENTAL MATERIALS CO .. LTDSHANGHAI FANTA DENTAL MATERIALS CO., LTD | 5 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Shanghai Fanta Dental Materials Co Ltd | 3 | 2019–2019 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SHANGHAI FANTA DENTAL MATERIALS Co., Ltd. | 3 | 2020–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SHANGHAI FANTA DENTAL MATERIALS CO., LTD. | 2 | 2022–2022 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SHANGHAI FANTA DENTAL MATERIALS CO., LTD. | 2 | 2019–2020 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Shanghai Fanta Dental Materials Co., Ltd. | 1 | 2026–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Shanghai Fanta Dental Materials Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Irrigation Needle | 2022 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | C-HANDLE-Endo File Holder | 2022 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Carbide Burs, Diamond Burs | 2025 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | DOWN PACK | 2022 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Lister | — | 2017 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | GUTTA PERCHA BAR | 2017 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Lister | — | 2017 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Lister | — | 2017 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Lister | — | 2017 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Lister | AF BABYAF BLUE R3AF BLUE ROTARYAF BLUE S ONEAF CLAF F ONEAF F ONE BLUEAF MAX1AF MAX1 BLUEAF MAX2 14 moreAF MAX2 BLUEAF MAX3AF MAX3 BLUEAF RETREATMENTAF ROTARYC-PATHC-PATH BLUEHarmonyStainless Steel H FILE, NiTi Rotary FileStainless Steel K FILE; C-FLEX FILEV-TAPER BLUEV-TAPER GOLDV-TAPER HANDV-TAPER ROTARY | 2017 |
| Endodontic BroachEKW · Class 1 | Endodontic files | Lister | — | 2017 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | 3D Tooth | 2022 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | Fiber Post | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SHANGHAI FANTA DENTAL MATERIALS CO., LTD.FDA reg. 3013538161 | Shanghai, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10054349). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.