Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013561919

FEI Number

3013561919

Entity Name

GUANGZHOU OO MEDICAL SCIENTIFIC LIMITED

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Add 1: Room 826, Building G1, No. 31 Kefeng Road, Huangpu District;, Add 2: Rm 203,Bldg 13,No. 8,Lianyun Rd, Guangzhou Guangdong 510670, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GUANGZHOU OO MEDICAL SCIENTIFIC LIMITED (Owner Number: 10054513)

Owner / Operator Contact Address

Add 1: Room 826, Building G1, No. 31 Kefeng Road, Huangpu District;, Add 2: Rm203,Bldg 13,No. 8,Lianyun Rd, Guangzhou, CN-GD 510670, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OO Dental, Massage Pillow, Fascia Gun, Massage Ggun, Eye Massager OO Dental, Orthodontic ligature ties OO Dental, Spring, Orthodontic OO Dental, OBRACE, O-EYES, Ceramic brackets OO Dental OO Dental, Disposable face mask; KN95 mask OO Dental, Retainer, Screw Expansion INDIRECT BONDING TRAY, OO Dental, OO MEDICAL, Orthodontic Indirect Bonding Tray, OBRACE GUIDE OO Dental, Orthodontic seperators OO Dental OO Dental, O-Tube FORCEPS, DRESSING, DENTAL, OO Dental, OO MEDICAL, Orthodontic Forceps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2024-04-23
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2023-11-21
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2024-12-08
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2017-03-28
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2021-07-04
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-05-07
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2024-12-08
QJJ	Indirect Bonding Tray	Dental	Class 1	872.5410	2025-12-30
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2023-11-21
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2017-03-28
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2020-11-27
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2025-12-30

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 OO MEDICAL SCIENTIFIC LIMITED

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
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

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

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3016460723	ZHEJIANG AOLIN INDUSTRY & TRADE CO., LTD.	Lishui Zhejiang, CN
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3009079475	Aerotel Ltd.	Holon Central, IL
3025350087	LENYO WORLD LTD	Budapest, HU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013561919. Last updated year: 2026. Please use registration number 3013561919 when referencing this establishment in official correspondence.