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Aditek Do Brasil, SA: FDA-registered device maker in CRAVINHOS Sao Paulo, Brazil, 3 510(k) clearances

Name: Aditek Do Brasil, SA FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Aditek Do Brasil, SA is registered with the FDA (registration 3003622434) in CRAVINHOS Sao Paulo, Brazil. It lists 12 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 27, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003622434
Address: 25, Santo Pierini Street, CRAVINHOS Sao Paulo, Brazil, 14140-000
Owner or operator: ADITEK DO BRASIL, SA (9104741)
Roles: Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer
First device listed: July 20, 2007
Registered through: 2026
Brand names listed: Active Clear, Active Clear+, Arcos Braided, Arcos Dupla Chave, Arcos Nitinol super elastico, Arcos TMA, Arcos de Aço, Arcos de Retração and more

Devices it lists

Device	Product code	Class	Role	Source
Adhesive, Bracket And Tooth Conditioner, Resin	DYH	2	Repackager or relabeler	accessdata.fda.gov
Aligner, Sequential	NXC	2	Contract manufacturer	accessdata.fda.gov
Band, Elastic, Orthodontic	ECI	1	Manufacturer	accessdata.fda.gov
Bracket, Ceramic, Orthodontic	NJM	2	Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Bracket, Metal, Orthodontic	EJF	1	Manufacturer	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Manufacturer	accessdata.fda.gov
Instrument, Ligature Tucking, Orthodontic	ECP	1	Manufacturer	accessdata.fda.gov
Maintainer, Space Preformed, Orthodontic	DYT	1	Contract manufacturer	accessdata.fda.gov
Retainer, Screw Expansion, Orthodontic	DYJ	1	Manufacturer	accessdata.fda.gov
Spring, Orthodontic	ECO	1	Manufacturer	accessdata.fda.gov
Tube, Orthodontic	DZD	1	Manufacturer	accessdata.fda.gov
Wire, Orthodontic	DZC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 27, 2016	K160957	CDB Self Ligating Bracket 8F	NJM	Substantially Equivalent	Cdb Corporation	accessdata.fda.gov
June 5, 2009	K090933	BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS	NJM	Substantially Equivalent	Forestadent Bernhard Forster GmbH	accessdata.fda.gov
August 10, 1979	K791132	SCI-PHARM ORTHODONTIC ADHESIVE	DYH	Substantially Equivalent	Scientific Pharmaceuticals, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 27, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.