Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026317445

FEI Number

3026317445

Entity Name

NANJING CHAMLION LASER TECHNOLOGY CO., LTD.

City/State/Country

Nanjing Jiangsu, CN

Establishment Address

Fengji Avenue 15, Building A02, Yuhuatai District, Nanjing city, China, Nanjing Jiangsu 210012, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Nanjing Chamlion Laser Technology Co., Ltd. (Owner Number: 10087040)

Owner / Operator Contact Address

Fengji Avenue 15, Building A02, Yuhuatai District, Nanjing city, China, Nanjing, CN-JS 210012, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dental selective laser melting Cobalt-based alloy powder,model:CoCrW Dental selective laser melting titanium alloy powder,model:TC4 Dental selective laser melting Pure Titanium powder,model:TA1 Zirconia Crown All-ceramic Dental Zirconia Block,model:98x10,98x12,98x14,98x16,98x18,98x20,98x22,98x25 Synthetic Polymer Teeth(ML2) Synthetic Polymer Teeth(L4) Synthetic Polymer Teeth(L5) Synthetic Polymer Teeth(S2) Synthetic Polymer Teeth(05) Synthetic Polymer Teeth(ML4) Synthetic Polymer Teeth(L3) Synthetic Polymer Teeth(TI) Synthetic Polymer Teeth(MU2) Synthetic Polymer Teeth(03) Synthetic Polymer Teeth(MU3) Synthetic Polymer Teeth(04) Synthetic Polymer Teeth(ML1) Synthetic Polymer Teeth(S4) Synthetic Polymer Teeth(T3) Synthetic Polymer Teeth(T2) Synthetic Polymer Teeth(ML5) Synthetic Polymer Teeth(L6) Synthetic Polymer Teeth(S5) Synthetic Polymer Teeth(02) Synthetic Polymer Teeth(T5) Synthetic Polymer Teeth(ML3) Synthetic Polymer Teeth(S1) Synthetic Polymer Teeth(MU5) Synthetic Polymer Teeth(L1) Synthetic Polymer Teeth(S3) Synthetic Polymer Teeth(T4) Synthetic Polymer Teeth(01) Synthetic Polymer Teeth(MU1) Synthetic Polymer Teeth(MU4) Synthetic Polymer Teeth(L2) Malo Bridge Chamlion-Dental Tray Chamlion-Dental Model

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2023-01-04
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2023-01-04
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2024-11-27
EKO	Denture Preformed (Partially Prefabricated Denture)	Dental	Class 2	872.3600	2023-11-27
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2023-11-27

Official Correspondent

Sun Zhifan

US Agent Details

Andy Smith Business: GRZAN GROUP INC. Email: info@grzan-ar.com Phone: (332) 2015192

Related Public Records

Same Entity

Nanjing Chamlion Laser Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K810521	C.Vaupel Dental, Inc.	CO-SPAN 13.5 CASTING ALLOY	1981-03-17
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03

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3039443707	SHANGHAI FRONTIER MATERIAL TECH CO., LTD.	Shanghai, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026317445. Last updated year: 2026. Please use registration number 3026317445 when referencing this establishment in official correspondence.