Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010517827

FEI Number

3010517827

Entity Name

Zhejiang Yahong Medical Apparatus Co., Ltd.

City/State/Country

Huzhou Zhejiang, CN

Establishment Address

No 788, Yongjun Road, Dipu street, Anji, Huzhou Zhejiang 313300, CN

Establishment Type(s)

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

Owner / Operator

Zhejiang Yahong Medical Apparatus Co., Ltd (Owner Number: 10045144)

Owner / Operator Contact Address

No 788, Yongjun Road, Dipu street, Anji, Huzhou, CN-ZJ 313300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Yahong W3 Yahong Yahong Yahong Yahong

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2013-10-23
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2019-12-06
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2013-10-23
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2013-10-23
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2013-10-23
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2013-10-23

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Zhejiang Yahong Medical Apparatus 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
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
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
3005663102	INMAN ORTHODONTIC LABORATORIES, INC.	CORAL SPRINGS, FL, US
3013508670	Ormco Corporation	Pomona, CA, US
3017352116	LACIGRUS INTERNATIONAL	Sialkot Punjab, PK
3016825318	MECMED MEDICAL	Sialkot Punjab, PK
9610612	AESCULAP AG	TUTTLINGEN, DONAU Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010517827. Last updated year: 2026. Please use registration number 3010517827 when referencing this establishment in official correspondence.