Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013102320

FEI Number

3013102320

Entity Name

CHENGDU BESMILE MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Chengdu Sichuan, CN

Establishment Address

No.9,Sec.2, Shengwucheng North Rd., Chengdu Tianfu International Bio-Town, Shuangliu District, Chengdu Sichuan 610200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Chengdu Besmile Medical Technology Co., Ltd. (Owner Number: 10089441)

Owner / Operator Contact Address

No.9,Sec.2, Shengwucheng North Rd., Chengdu Tianfu International Bio-Town, Shuangliu District, Chengdu, CN-SC 610200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Customized Abutment and Screw Dental Glass Ceramics ACRYLIC DENTURE FULL DENTURE IMMEDIATE DENTURE Drill REMOVABLE PARTIAL DENTURE FLEXIBLE DENTURE PARTIAL DENTURE Dental Porcelain Powder BIORES Dental Implant System Pre-Sintered Zirconia Coloring Liquid Cosmetic Denture Full Ceramic Restoration Zirconia Crown / Bridge Porcelain Restoration Porcelain-Fused-To-Metal Restoration

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-09-09
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2024-01-24
NSL	Dentures, Full	Unknown	Class N	N/A	2023-12-25
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2026-05-21
NSK	Dentures, Partial	Unknown	Class N	N/A	2023-12-25
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2024-01-24
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2026-02-09
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2026-02-09
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2024-03-25
NXJ	Denture, Cosmetic Only	Unknown	Class N	N/A	2023-12-25
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2023-12-25
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2023-12-25

Official Correspondent

Moushan Liu

US Agent Details

JAMES ST. WU Business: HUMISS INC. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

Chengdu Besmile Medical 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
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain

Similar Registrations

Registration Number	Establishment Name	Location
3013578168	DDS CARIBBEAN CORP	Guaynabo, PR, US
3030690317	TRATE LLC	Tamarac, FL, US
3011587077	JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.	Changzhou Jiangsu, CN
3012121192	DENTAL EVOLUTIONS, INC	Beverly Hills, CA, US
3031529635	TRATE UAB	Kaunas Kauno Apskritis, LT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013102320. Last updated year: 2026. Please use registration number 3013102320 when referencing this establishment in official correspondence.