Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027343382

FEI Number

3027343382

Entity Name

UNIVY TECHNOLOGY ADVANCED CO. LTD

City/State/Country

Shanghai, CN

Establishment Address

Room 912, No. 336, Jialuo Highway, Jiading District, Shanghai 201822, CN

Establishment Type(s)

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

Owner / Operator

Univy Technology Advanced Co. Ltd (Owner Number: 10087835)

Owner / Operator Contact Address

Room 912, No. 336, Jialuo Highway, Jiading District, Shanghai, CN-SH 201822, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthodontic metal brackets Orthodontic arch wire Buccal tubes Gutta Percha Orthodontic elastic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2023-04-22
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2023-04-22
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2023-04-22
EKM	Gutta-Percha	Dental	Class 1	872.3850	2025-12-18
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2023-04-22

Official Correspondent

Ryan Zhou

US Agent Details

Anna SUN Business: SUN LUNA STAR LLC Email: usa@medpath.pro Phone: (626) 2005096

Related Public Records

Same Entity

Univy Technology Advanced 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
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

Registration Number	Establishment Name	Location
3010462491	DW Lingual Systems GmbH	Bad Essen Lower Saxony, DE
3009257060	Ortho Traction Pads	Norwalk, CT, US
3023443842	HENAN BAISTRA MEDICAL DEVICES LIMITED	Zhengzhou Henan, CN
3012232878	SUNSTAR TRADING INTERNATIONAL LIMITED	Kowloon Hong Kong, CN
3032911850	Solventum Germany GmbH	Kamen North Rhine-Westphalia, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027343382. Last updated year: 2026. Please use registration number 3027343382 when referencing this establishment in official correspondence.