Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003622434

FEI Number

3003622434

Entity Name

ADITEK DO BRASIL, SA

City/State/Country

CRAVINHOS Sao Paulo, BR

Establishment Address

25, SANTO PIERINI STREET, CRAVINHOS Sao Paulo 14140-000, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ADITEK DO BRASIL, SA (Owner Number: 9104741)

Owner / Operator Contact Address

25, SANTO PIERINI STREET, --, CRAVINHOS, BR-SP 14140-000, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BioClip PI BioClip EasyClip + EasyClip BioMax Vector One Piece Vector+ Vector+ Biocross Niti Open Coil Springs Niti Closed Coil Springs Niti Closed Coil TAD Spring Niti Molar Distalizing Spring Bite Turbo Active Clear+ Clear Aligner (EAB II) Memoflex Copolyester; Memoflex PETG; Memoflex TPU Twist Flex Coaxial Wire Mola Nitinol Distalização Fio Aço Arcos Braided Mola Nitinol aberta Arcos Dupla Chave Fio Elgiloy Arcos de Retração Arcos de Aço Nitinol Contour Niti Mola Nitinol de Retração Arcos TMA Nitinol termoativado Atcos Nitinol Curva Reversa Fio TMA Arcos Nitinol super elastico EasyClip+ opening tool EasyClip+ closing tool

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2007-07-20
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2015-11-26
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2026-03-05
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2018-05-11
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2025-04-08
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2017-05-12
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2025-09-16
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2013-09-13
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2016-12-15

Official Correspondent

EDUARDO LOPES

US Agent Details

Bill Jacqmein Email: bjacqmein@primepathmedtech.com Phone: (404) 2166190

Related Public Records

Same Entity

ADITEK DO BRASIL, SA

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
K180404	3M Healthcare	3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System	2018-03-16
K161684	Reliance Orthodontic Products, Inc.	Quantum LB	2016-10-06
K810210	Sci-Pharm, Inc.	MAGIC-TOUCH	1981-02-10

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3023443842	HENAN BAISTRA MEDICAL DEVICES LIMITED	Zhengzhou Henan, CN
3012232878	SUNSTAR TRADING INTERNATIONAL LIMITED	Kowloon Hong Kong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003622434. Last updated year: 2026. Please use registration number 3003622434 when referencing this establishment in official correspondence.