Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004645512

FEI Number

3004645512

Entity Name

BEIJING SMART TECHNOLOGY CO., LTD.

City/State/Country

Beijing, CN

Establishment Address

Room 401, Block C, Lvhai Tower, 2 Yongcheng North Road, Beijing 100094, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BEIJING SMART TECHNOLOGY CO., LTD. (Owner Number: 9065003)

Owner / Operator Contact Address

Room 401, Block C, Lvhai Tower, 2 Yongcheng North Road, BEIJING, CN-BJ 100094, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Smart Orthomechanics Preformed NiTi Retainer Smart Orthomechanics

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2004-07-15
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2020-11-25
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2004-07-15

Official Correspondent

LIN LIN

US Agent Details

Rose Hou Business: ORJ USA Email: roseh@fortuneworldwide.com Phone: (214) 2564188

Related Public Records

Same Entity

BEIJING SMART 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
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004645512. Last updated year: 2026. Please use registration number 3004645512 when referencing this establishment in official correspondence.