Manufacturer registered with FDA
Suzhou laixin 3D Technology Co.,Ltd
Suzhou, China. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 19
- 510(k) clearances
- 0as applicant
- Markets registered in
- 216 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Suzhou laixin 3D 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 | Suzhou laixin 3D Technology Co.,Ltd | 5 device types | — | Below |
| European Union | EUDAMED | Manufacturer | SUZHOU LAIXIN 3D TECHNOLOGY CO., LTD. | 16 | — | 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 Suzhou laixin 3D 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 Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | NightGuard Resin (NightGuard, NightGuard Hard, NightGuard Soft)Splint Resin (Splint, Splint Flex, Splint Flexi, Splint Hard, Splint Soft, DentalGuard, Dental Clear) | 2023 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Cast Resin (Cast, Cast-Wax)Model Resin (DB Flex, DB Impact, DC, DT Dark, DT Dark Meharry 2, DT Dark Pink, DT Light, DT Light Pink)Model Resin (DT Light Pink 2, DT, DT Pink 2, DT Pink, DT Clear Pink, Dental Teeth, Dental Teeth Plus, FlexiDenture)Model Resin (FlexiDenture Pink, FlexiDenture Dark Pink, IBT, Print Teeth, Record model, Soft , Soft Pink, TempraTeeth)Model Resin (Model DM 2, Model E, Model Pro, Model Pro Ivory, Model Pro Grey, Model Pro Grey, Model Pro Orange)Model Resin (Model Pro Orange, Model Pro Pink, Model Pro A2, Model Pro A3, Model S, Model SH, Model TR, Model TR Orange)Model Resin (Model TR Grey, Model Ultra, Model RX, Model RX Pro, Model WW, Model XE, Model XE Apricot, Model XE Grey)Model Resin (Model XE Pink, Model X, Model Y, Ortho model, Ortho Model 2, CB, Crown ULTRA, Crown ULTRA DT, Crown X)Model Resin (Model, Model 1, Model 1 Orange, Model 1 Grey, Model 1 Ivory, Model 1 Pink, Model 1 A2, Model C, Model DM)Model Resin (TT C&B BL1, Temp Crown) 2 moreModel Resin (TT, TT A1, TT A2, TT A3, TT C&B, TT C&B A1, TT C&B A2, TT C&B A3, TT C&B A3.5, TT C&B B1, TT C&B B2)Tray Resin (Tray, Tray Purple, Tray Red, Tray Blue) | 2023 |
| Shellac Base PlateEEA · Class 1 | — | Maker | Try-in Resin (Try-in, Try in A2, Try in A3, Denture Try-in, Denture Base Impact Try-in, Denture Base Flex Try-in) | 2023 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Surgical Guide Resin (SG, SG V2, SG Clear, SG2, SG HT, Surgical Guide, Dental Guide, Guide&Tray) | 2023 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | Dental Teeth (A1,A2,A3,A3.5,B1,B2,B3,Bleach,C2)Dental Teeth Plus (A1,A2,A3,A3.5,B1,B2,B3,Bleach,C2)Print teeth (A1,A2,A3,A3.5,B1,B2,B3,Bleach,C2) | 2025 |
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 |
|---|---|---|
| SUZHOU LAIXIN 3D TECHNOLOGY CO.,LTDFDA reg. 3027508795 | Suzhou Jiangsu, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10087931). 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.