SUZHOU LAIXIN 3D TECHNOLOGY CO.,LTD

FDA Device Registration & Listing · Suzhou Jiangsu, CN · Registration 3027508795

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3027508795
FEI Number
3027508795
Entity Name
SUZHOU LAIXIN 3D TECHNOLOGY CO.,LTD
City/State/Country
Suzhou Jiangsu, CN
Establishment Address
Building 1, No. 9, Suhong West Road, Suzhou Industrial Park, Suzhou Area, China (Jiangsu) Pilot Free Trade Zone, Suzhou Jiangsu 215000, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Suzhou laixin 3D Technology Co.,Ltd (Owner Number: 10087931)
Owner / Operator Contact Address
Building 1, No. 9, Suhong West Road, Suzhou Industrial Park, Suzhou Area, China (Jiangsu) Pilot Free Trade Zone, Suzhou, CN-JS 215000, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Try-in Resin Try-in, Denture Try-in Denture Base Flex Try-in,Denture Base Impact Try-in, Try in A2 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 Dental Teeth, A1,A2,A3,A3.5,B1,B2,B3,Bleach,C2 Model 1 Ivory, Model XE, Model XE Apricot, Model XE Grey, Model WW, Cast-Wax, Model Pro Orange Tray Purple, IBT, Soft Pink,Cast, Model, Ortho model, Record model, Model 1, Model 1 Orange, Model 1 Grey Model Resin Model Pro Grey, Model Pro Ivory, Model C, Model XE Pink, Model TR Orange, Model TR Grey DB Impact,DB Flex,DT Light Pink,Model RX,DT Pink 2,DT Light Pink 2,DT Dark Meharry 2,Print Teeth,Dental Teeth Model Pro Orange,Model DM,Model DM 2,Ortho Model 2,DC,CB ,Model E,Model Ultra,Model S,Model Y,Model X,Model Pro TempraTeeth,CrownX,Temp Crown,Crown ULTRA,Dental Teeth Plus DT Pink,TT A1 ,TT A2 ,TT A3 ,TT C&B A1,TT C&B A2,TT C&B A3,FlexiDenture Pink,FlexiDenture Dark Pink,Model Pro Grey Gingiva, Gingiva Mask, Soft Pink 2 Gingiva Resin Surgical Guide Resin SG, SG Clear, Surgical Guide, Dental Guide, Guide&Tray, SG2 SG V2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EEA Plate, Base, Shellac Dental Class 1 872.6200 2023-05-03
PZY Additively Manufactured, Preformed, Resin Denture Tooth Dental Class 2 872.3590 2025-12-02
EBH Material, Impression Tray, Resin Dental Class 1 872.3670 2023-05-03
NOK Material, External Aesthetic Restoration, No Adhesive General, Plastic Surgery Class 1 878.3800 2023-10-19
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2023-05-03

Official Correspondent

Qishan Cai

US Agent Details

HERY ZHOU Business: CIIC Technology Service Email: zjy0926@outlook.com Phone: (708) 5994325

Related Public Records

Same Entity

Suzhou laixin 3D Technology Co.,Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027508795. Last updated year: 2026. Please use registration number 3027508795 when referencing this establishment in official correspondence.
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