Manufacturer registered with FDA
Changsha Easyinsmile Intelligence Technology Co.,Ltd.
Changsha, China. Lists 15 dental device types with FDA across 1 registered establishment.
- Device types listed
- 15
- Brands and models
- 16
- 510(k) clearances
- 0as applicant
- Markets registered in
- 618 registrations outside the US
- Establishments
- 1China
Registered in 6 markets
Where regulators' registries name Changsha Easyinsmile Intelligence Technology 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 | Changsha Easyinsmile Intelligence Technology Co.,Ltd. | 15 device types | — | Below |
| Taiwan | TFDA | Manufacturer | Changsha Easyinsmile Intelligence Technology Co., Ltd. | 8 | 2020–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Changsha Easyinsmile Intelligence Technology Co., Ltd. | 7 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Changsha Easyinsmile Intelligence Technology Co Ltd | 1 | 2025–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | Changsha EasyinSmile Intelligence Technology Co., Ltd. | 1 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Changsha Easyinsmile Intelligence Technology Co., Ltd. | 1 | 2025–2025 | 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 Changsha Easyinsmile Intelligence Technology 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 |
|---|---|---|---|---|
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Maker | Band, Material, Orthodontic | 2023 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Orthodontic wire Models COLOR CODE, SS,NITI,BETA-II,COIL-I | 2023 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Tube | 2023 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Dental Strip | 2020 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Mouth opener | 2020 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Oral photodynamic therapy device ModeLight PDT 630, Light PDT B | 2024 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Orthodontic Metal Bracket models: DO-I,DO-II,DO-III,DO-IV,CNS-I,CNS-II,CNS-III,CNS-IV | 2021 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Photosensitizer Models: High, Medium, Low | 2024 |
| Operative Matrix Contouring InstrumentEKF · Class 1 | Dental hand instruments | Maker | Matrices Refill Sectional contoured metal | 2021 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Endodontic File Models X-TAPER,G3-PRO GOLD,X-ONE,X3,X-CORN,X-PRO GOLD,X-RECIPORC,X-RETREATMENTX-TWO-S,X-ULTRASONIC,X-BABY,X3-MAX,X-PATH,K FILE,H-FILE,R-FILE,S-FILE,C-FILE | 2023 |
| Preformed CrownELZ · Class 1 | — | Maker | Dental Crown | 2024 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | X-root Sealer Dental cement | 2023 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Easydo Activator | 2021 |
| Acacia and Karaya with Sodium Borate Denture AdhesiveKOM · Class 1 | — | Maker | Adhesive, Denture, Acacia And Karaya With Sodium Borate models X-SMALL,X-LARGE | 2023 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Implant detector | 2021 |
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 |
|---|---|---|
| Changsha Easyinsmile Intelligence Technology Co.Ltd.FDA reg. 3015548849 | Changsha Hunan, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10064889). 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.