Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034693059

FEI Number

3034693059

Entity Name

ORTHGUIDE MEDICAL TECHNOLOGY (JIANGSU) CO., LTD

City/State/Country

Wuxi City Jiangsu, CN

Establishment Address

3rd Floor, Building D5, Life Science Park, Zone D, Huishan District, Wuxi City, Jiangsu Province, Wuxi City Jiangsu 214174, CN

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Orthguide Medical Technology (jiangsu) Co., Ltd (Owner Number: 10092062)

Owner / Operator Contact Address

3rd Floor, Building D5, Life Science Park, Zone D, Huishan District, Wuxi City, Jiangsu Province, Wuxi City, CN-JS 214174, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

orthguide orthguiede orthguide orthguide

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2024-11-29
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2024-11-29
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2024-11-29
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2025-05-21
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2024-11-29
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2024-11-29
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2024-11-29
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2024-11-29
ECT	Driver, Band, Orthodontic	Dental	Class 1	872.4565	2024-11-29
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2024-11-29
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2024-11-29
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2024-11-29
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2024-11-29
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2024-11-29

Official Correspondent

Lanyan Li

US Agent Details

Frank Zhuang Business: Frank Zhuang Email: Frank@laoakgroup.com Phone: (213) 5597669

Related Public Records

Same Entity

Orthguide Medical Technology (jiangsu) 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

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3007962015	ORTHODENTALUSA CORP.	Weston, FL, US
3006237499	MODERN ORTHODONTICS	LUDHIANA, PUNJAB, IN
3002769844	ACME ENTERPRISES	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034693059. Last updated year: 2026. Please use registration number 3034693059 when referencing this establishment in official correspondence.