Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027323119

FEI Number

3027323119

Entity Name

HANGZHOU ORTHMAY ADVANCED MATERIALS TECHNOLOGY CO., LTD

City/State/Country

Hangzhou City Zhejiang, CN

Establishment Address

Room B2-2-205, Building 2, No. 181, Wuchang Avenue, Wuchang Street, Yuhang District, Hangzhou City Zhejiang 311100, CN

Establishment Type(s)

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

Owner / Operator

Hangzhou Orthmay Advanced Materials Technology Co., Ltd (Owner Number: 10087622)

Owner / Operator Contact Address

Room B2-2-205, Building 2, No. 181, Wuchang Avenue, Wuchang Street, Yuhang District, Hangzhou City, CN-ZJ 311100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

B103-21 Bondable 1st Convertible Slot 022 Edgewise Buccal Tube; B212-11 Bondable 2nd Non-Convertible Slot 018 MBT Buccal Tube B111-21 Bondable 1st Convertible Slot 022 MBT Buccal Tube; B108-11 Bondable 1st Non-Convertible Slot 018 Roth Buccal Tube; B208-11 Bondable 2nd Non-Convertible Slot 018 Roth Buccal Tube; B104-21 Bondable 1st Non-Convertible Slot 022 Edgewise Buccal Tube; B208-21 Bondable 2nd Non-Convertible Slot 022 Roth Buccal Tube; B107-21 Bondable 1st Convertible Slot 022 Roth Buccal Tube; B108-21 Bondable 1st Non-Convertible Slot 022 Roth Buccal Tube; B212-21 Bondable 2nd Non-Convertible Slot 022 MBT Buccal Tube. B204-11 Bondable 2nd Non-Convertible Slot 018 Edgewise Buccal Tube; B112-11 Bondable 1st Non-Convertible Slot 018 MBT Buccal Tube; B204-21 Bondable 2nd Non-Convertible Slot 022 Edgewise Buccal Tube; Orthodontic Tube (B102-21 Weldable 1st Non-Convertible Slot 022 Edgewise Buccal Tube; B110-21 Weldable 1st Non-Convertible Slot 022 MBT Buccal Tube; B106-21 Weldable 1st Non-Convertible Slot 022 Roth Buccal Tube; B112-21 Bondable 1st Non-Convertible Slot 022 MBT Buccal Tube; B104-11 Bondable 1st Non-Convertible Slot 018 Edgewise Buccal Tube; Orthodontic Plier Orthodontic Band A212-21 Bondable Mini with hook on 3,4,5 Slot 022 Roth Self Ligating Bracket; A204-21 Bondable Mini with hook on 3,4,5 Slot 022 Edgewise Bracket; A116-21 Monoblock Mini with hook on 3,4,5 Slot 022 MBT Bracket; Orthodontic Bracket, Lingual Button; A204-11 Bondable Mini with hook on 3,4,5 Slot 018 Edgewise Bracket; A213-21 Bondable Standard No Hook Slot 022 MBT Bracket; A108-21 Monoblock Mini with hook on 3,4,5 Slot 022 Roth Bracket; A120-21 Monoblock Mini with hook on 3,4,5 Slot 022 MBT Self Ligating Bracket; A208-21 Bondable Mini with hook on 3,4,5 Slot 022 Roth Bracket; A220-21 Bondable Mini with hook on 3,4,5 Slot 022 MBT Self Ligating Bracket. A218-21 Bondable Standard with hook on 3,4,5 Slot 022 MBT Self Ligating Bracket; A214-21 Bondable Standard with hook on 3,4,5 Slot 022 MBT Bracket; A208-11 Bondable Mini with hook on 3,4,5 Slot 018 Roth Bracket; A205-21 Bondable Standard No Hook Slot 022 Roth Bracket; A216-21 Bondable Mini with hook on 3,4,5 Slot 022 MBT Bracket; A203-21 Bondable Mini No Hook Slot 022 Edgewise Bracket; A215-21 Bondable Mini No Hook Slot 022 MBT Bracket; A207-21 Bondable Mini No Hook Slot 022 Roth Bracket; A206-21 Bondable Standard with hook on 3,4,5 Slot 022 Roth Bracket; A104-21 Monoblock Mini with hook on 3,4,5 Slot 022 Edgewise Bracket; A210-21 Bondable Standard with hook on 3,4,5 Slot 022 Roth Self Ligating Bracket; A202-21 Bondable Standard with hook on 3,4,5 Slot 022 Edgewise Bracket;

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2023-03-21
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2023-03-21
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2023-03-21
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2023-03-21

Official Correspondent

Lihua Chen

US Agent Details

Hui Hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (302) 8000162

Related Public Records

Same Entity

Hangzhou Orthmay Advanced Materials 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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

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3032027578	Solventum Orthodontics Corporation	Monrovia, CA, US
1526352	SUMMIT ORTHODONTIC SERVICES, INC.	Schaumburg, IL, US
3014425175	Sharp Detail Orthodontic Laboratory S DE EL DE CV	Tijuana Baja California, MX
3015337428	GUANGZHOU CHEER-U MATERIAL TECHNOLOGY CO., LTD	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027323119. Last updated year: 2026. Please use registration number 3027323119 when referencing this establishment in official correspondence.