Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013641573

FEI Number

3013641573

Entity Name

ORTHOMETRIC IND. E COM. DE PROD. MED. ODONT.

City/State/Country

Marilia Sao Paulo, BR

Establishment Address

Rua Irineu Martins, 280, Marilia Sao Paulo 17539059, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Orthometric Ind. e Com. de Prod. Med. Odont. (Owner Number: 10056882)

Owner / Operator Contact Address

Rua Irineu Martins, 280, Marília, BR-SP 17539059, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ORTHOMETRIC BANDS ORTHOMETRIC BUR U-CLIP BRACKETS PREMIUM ELITE BRACKETS PREMIUM SERIES BRACKETS ULTRA-P BRACKETS ADVANCED SERIES BRACKETS LINEA D2 BRACKETS ORTHOMETRIC SMS BRACKETS BIOVERSATIL BRACKETS CAPELOZZA BRACKETS LEDX-PRO ORTHOMETRIC ELASTOMERICS - INTRA ORAL ORTHOMETRIC ELASTOMERICS - SEPARATOR ORTHOMETRIC ELASTOMERICS - EXTRA ORAL ORTHOMETRIC ELASTOMERICS - PACKING FOR PATIENT ORTHOMETRIC ELASTOMERICS - CHAIN ORTHOMETRIC ELASTOMERICS - ELASTIC POSITIONER ORTHOMETRIC ELASTOMERICS - MODULAR LIGATURE ORTHOMETRIC ELASTOMERICS - STICK LIGATURE SKY CHOICE PATIENT STICK TIES SKY CHOICE ELASTIC CHAIN ORTHOMETRIC ELASTOMERICS NON-LATEX ORTHOMETRIC ELASTOMERICS - BLACK LATEX ORTHOFLEXY ELASTOMERIC ORTHOMETRIC SS - CrNi - BRAIDED RHODIUM ORTHOMETRIC BETA FLEXY ORTHOMETRIC STRAIGHT WIRE BETA FLEXY FLEXY NiTi REVERSE CURVE ORTHOMETRIC SS - CrNi - BRAIDED SS ORTHOMETRIC ARCHWIRES KIT FLEXY NiTi THERMO ACTIVE ORTHOMETRIC SS - CrNi ORTHOMETRIC SS - CrNi - STRAIGHT WIRE ORTHOMETRIC RHODIUM ARCHWIRES SEQUENCE ORTHOMETRIC COLBOLOY - CrCo FLEXY NiTi - ARCHWIRES KIT FLEXY NiTi SUPER ELASTIC RHODIUM LINEA ARCHWIRES FLEXY NiTi COPPER RHODIUM FLEXY NiTi SUPER ELASTIC BIOVERSATIL ARCHWIRES ORTHOMETRIC SS CrNi RHODIUM ORTHOMETRIC SS - CrNi - WIRE FOR LIGATURE FLEXY NiTi COPPER - CuNiTi ORTHOMETRIC ACETATE TRACING PAPER FLEXY NITI DISTALIZING OPEN SPRING FLEXY NITI CLOSED SPRING FLEXY NITI OPEN SPRING ICERAM CLEAR DISTALIZER BIOVERSATIL TUBES LINEA TUBES ADVANCED SERIES TUBES PREMIUM SERIES TUBES ICERAM MINI TUBES CAPELOZZA TUBES MJANSON TUBES NANO TUBES ORTHOCHEWIE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2018-06-04
EJL	Bur, Dental	Dental	Class 1	872.3240	2022-03-17
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2018-01-26
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2023-01-20
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2018-01-26
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2018-01-26
EFH	Paper, Articulation	Dental	Class 1	872.6140	2022-03-21
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2022-03-17
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2023-05-17
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2018-01-26
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2023-05-17

Official Correspondent

Orthometric Industria e Comercio LTDA

US Agent Details

Bruno Souza Business: BHP CONSULTING LLC Email: usagent@bhpconsulting.net Phone: (301) 4448132

Related Public Records

Same Entity

Orthometric Ind. e Com. de Prod. Med. Odont.

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
K243921	Foshan Coxo Medical Instrument Co., Ltd.	LED Curing Lights (DB686 HALO)	2025-04-11
K033201	Apoza Enterprise Co., Ltd.	LA500 BLUE LIGHT	2003-12-02
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
3007962015	ORTHODENTALUSA CORP.	Weston, FL, US
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

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013641573. Last updated year: 2026. Please use registration number 3013641573 when referencing this establishment in official correspondence.