Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015337428

FEI Number

3015337428

Entity Name

GUANGZHOU CHEER-U MATERIAL TECHNOLOGY CO., LTD

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Room #213, Building #4, No. 20 Guanda Road, Huangpu District, Guangzhou Guangdong 510700, CN

Establishment Type(s)

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

Owner / Operator

Guangzhou Cheer-U Material Technology Co., Ltd (Owner Number: 10083551)

Owner / Operator Contact Address

Room #213, Building #4, No. 20 Guanda Road, Huangpu District, Guangzhou, CN-GD 510700, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Retainer, Screw Expansion, Orthodontic, Expansion Screw Orthodontic Tube Preformed Orthodontic Band Powered toothbrush, Orthodontic Tooth Brush Clamp, wire, orthodontic, Lingual button, CLAMP, WIRE, ORTHODONTIC, Crimpable Tubes, Crimpable Hook Orthodontic Wire Orthodontic Elastic Band Spring, Orthodontic, Spings (Open, Close, Niti) Facebow, Facebow Orthodontic Metal Bracket, Orthodontic Metal Bracket, Ceramic brackets Mouth Mirror Orthodontic Band Material

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2026-02-09
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2021-11-30
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2021-11-30
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2024-01-23
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2024-12-12
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2021-11-30
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2021-11-30
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2026-02-09
KCR	Facebow	Dental	Class 1	872.3220	2024-12-12
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2021-11-30
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2021-11-30
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2021-11-30

Official Correspondent

Cathy Guo

US Agent Details

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

Related Public Records

Same Entity

Guangzhou Cheer-U Material 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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2012	Biomet Microfixation, Inc.	1	Biomet Microfixation outer packaging labeled in part:"REF: SP-2411*RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN**" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.

Similar Registrations

Registration Number	Establishment Name	Location
3017092365	APNOMED, INC.	Bellevue, WA, US
1000385618	LEWA-DENTAL GMBH & CO. KG	REMCHINGEN Baden-Wurttemberg, DE
3009687180	KTJ DENTAL LAB COMPANY LIMITED	KL, HK
3024749697	SPRINTRAY INC.	Huntington Beach, CA, US
3036547408	NAM A DENTAL MEDICINE COMPANY LIMITED	Thong Tay Hoi Ward Ho Chi Minh, VN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015337428. Last updated year: 2026. Please use registration number 3015337428 when referencing this establishment in official correspondence.