HANGZHOU DTC MEDICAL APPARATUS CO., LTD

FDA Device Registration & Listing · Hangzhou Zhejiang, CN · Registration 3009955691

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
3009955691
FEI Number
3009955691
Entity Name
HANGZHOU DTC MEDICAL APPARATUS CO., LTD
City/State/Country
Hangzhou Zhejiang, CN
Establishment Address
Floor 1-3, Building 2, 8 Xiyuan Road, Xihu District,, Hangzhou Zhejiang 310030, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Hangzhou DTC Medical Apparatus Co., Ltd (Owner Number: 10049604)
Owner / Operator Contact Address
Floor 1-3, Building 2, 8 Xiyuan Road, Xihu District,, Hangzhou, CN-ZJ 310030, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Dental Brackets;DTC;Orthodontics DTC;Orthodontics Dental Bands;DTC;Orthodontics Dental Mirror;DTC;Orthodontics Dental Brackets;DTC;Orthodontics Arch Wires;DTC;Orthodontics Expansion Screw;DTC;Orthodontics Dental Tubes;Buccal Tubes;DTC;Orthodontics

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ECQ Aligner, Bracket, Orthodontic Dental Class 1 872.4565 2015-06-26
ECO Spring, Orthodontic Dental Class 1 872.5410 2015-06-26
ECM Band, Preformed, Orthodontic Dental Class 1 872.5410 2015-06-26
EAX Mirror, Mouth Dental Class 1 872.4565 2016-06-06
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2015-06-26
ECN Clamp, Wire, Orthodontic Dental Class 1 872.5410 2015-06-26
DYJ Retainer, Screw Expansion, Orthodontic Dental Class 1 872.5410 2015-06-26
DZD Tube, Orthodontic Dental Class 1 872.5410 2015-06-26

Official Correspondent

Jaymie Kang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Hangzhou DTC Medical Apparatus 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
K894358 Ormco Corp. LUMINA ORTHODONTIC BRACKET 1989-09-15
K925012 American Orthodontics PLASTIC CHAIN 1993-09-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009955691. Last updated year: 2026. Please use registration number 3009955691 when referencing this establishment in official correspondence.
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