Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009233378

FEI Number

3009233378

Entity Name

GUANGZHOU RITON BIOMATERIAL CO., LTD

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

R402, 4F, R501-502, 5F, No.29 Luoxuan Rd 3, Guangzhou International Bioisland, Huangpu District, Guangzhou Guangdong 510005, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangzhou Riton Biomaterial Co., LTD (Owner Number: 10043584)

Owner / Operator Contact Address

R402, 4F, R501-502, 5F, No.29 Luoxuan Rd 3, Guangzhou International Bioisland, Huangpu District, Guangzhou, Guangzhou, CN-GD 510005, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

eLock Buccal Bracket Customized Lingual Orthodontic Bracket eLock Lingual 3D Bracket eLock Lingual 2D Bracket Stepwise Lingual Appliance

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2013-03-01

Official Correspondent

Zu'an Li

US Agent Details

Jeffery Charles Coons Business: Kanglife US, LLC Email: info@kanglifeus.com Phone: (720) 3094720

Related Public Records

Same Entity

Guangzhou Riton Biomaterial 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 3009233378. Last updated year: 2026. Please use registration number 3009233378 when referencing this establishment in official correspondence.