Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009011037

FEI Number

3009011037

Entity Name

MEM DENTAL TECHNOLOGY CO LTD

City/State/Country

Tainan, TW

Establishment Address

2F & 4F, No.22, and 2F, No. 26, Lane 31, Sec.1, Huandong Rd., Xinshi Dist., Tainan 74146, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEM DENTAL TECHNOLOGY CO LTD (Owner Number: 10037177)

Owner / Operator Contact Address

2F., No.22, Lane 31, Sec.1, Huandong Rd., Xinshi Dist., Tainan, TW-TNN 74146, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MEM Aligner Crimpable Hook

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2019-12-04
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2025-06-09
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2011-06-23
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2014-03-12
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2011-06-23
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2011-06-23
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2011-06-23
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2024-02-07
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2011-06-23

Official Correspondent

Maggie Wei

US Agent Details

CHRISTOPHER MAO Email: maochris@quarlink-usa.com Phone: (818) 6601161

Related Public Records

Same Entity

MEM DENTAL 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
K180404	3M Healthcare	3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System	2018-03-16
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
2024980	YOUNG INNOVATIONS INC.	Algonquin, IL, US
3027460334	LightForce Orthodontics	Wilmington, MA, US
3016543896	CSY INTERNATIONAL LLC	Rancho Cucamonga, CA, US
1000118628	FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC.	Denton, TX, US
1833132	G & H Wire Company	Franklin, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009011037. Last updated year: 2026. Please use registration number 3009011037 when referencing this establishment in official correspondence.