Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007962015

FEI Number

3007962015

Entity Name

ORTHODENTALUSA CORP.

City/State/Country

Weston, FL, US

Establishment Address

1500 Weston Rd Ste 204, Weston, FL 33326, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

ORTHODENTALUSA CORP. (Owner Number: 10031414)

Owner / Operator Contact Address

1500 weston Rd., Suite 204, Weston, FL 33326, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KASO MEDICAL TECHNOLOGY Co., LTD ORTHODENTALUSA CORP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2015-04-14
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2015-04-14
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2015-04-14
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2016-03-17
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2015-04-14
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2015-04-14
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2015-04-14
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2015-04-14
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2015-04-14
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2015-04-14
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2015-04-14
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2015-04-14
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2015-04-14

Official Correspondent

Luis Cardenas

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ORTHODENTALUSA CORP.

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

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
3009171220	DENTIMED SAO JOAO	Sunrise, FL, US
3027257639	YANGJIANG KAIMI IMPORT EXPORT CO.,LTD	Yangjiang Guangdong, CN
2126683	AMERICAN ORTHODONTICS	SHEBOYGAN, WI, US
3006946041	OSSTEM ORTHODONTICS Inc.	Uiwang-si Gyeonggi, KR
3026326493	ZHEJIANG YAMEI MEDICAL EQUIPMENT TECHNOLOGY CO., LTD.	Yang Jiao Lang Zin'an Town Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007962015. Last updated year: 2026. Please use registration number 3007962015 when referencing this establishment in official correspondence.