Data / Medical devices / Brazil / Orthometric Ind. E Com. De Prod. Med. Odont.

Orthometric Ind. E Com. De Prod. Med. Odont.: FDA-registered device maker in Marilia Sao Paulo, Brazil, 2 510(k) clearances

Name: Orthometric Ind. E Com. De Prod. Med. Odont. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Orthometric Ind. E Com. De Prod. Med. Odont. is registered with the FDA (registration 3013641573) in Marilia Sao Paulo, Brazil. It lists 17 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 4, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013641573
Address: Rua Irineu Martins, 280, Marilia Sao Paulo, Brazil, 17539059
Owner or operator: Orthometric Ind. e Com. de Prod. Med. Odont. (10056882)
Roles: Manufacturer, Repackager or relabeler
First device listed: January 26, 2018
Registered through: 2026
Brand names listed: ADVANCED SERIES BRACKETS, ADVANCED SERIES TUBES, BIOVERSATIL ARCHWIRES, BIOVERSATIL BRACKETS, BIOVERSATIL TUBES, CAPELOZZA BRACKETS, CAPELOZZA TUBES, FLEXY NITI CLOSED SPRING and more

Devices it lists

Device	Product code	Class	Role	Source
Activator, Ultraviolet, For Polymerization	EBZ	2	Repackager or relabeler	accessdata.fda.gov
Band, Elastic, Orthodontic	ECI	1	Manufacturer	accessdata.fda.gov
Band, Material, Orthodontic	DYO	1	Manufacturer	accessdata.fda.gov
Bracket, Ceramic, Orthodontic	NJM	2	Manufacturer	accessdata.fda.gov
Bracket, Metal, Orthodontic	EJF	1	Manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Manufacturer	accessdata.fda.gov
Clamp, Wire, Orthodontic	ECN	1	Manufacturer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Repackager or relabeler	accessdata.fda.gov
Paper, Articulation	EFH	1	Repackager or relabeler	accessdata.fda.gov
Plier, Orthodontic	JEX	1	Repackager or relabeler	accessdata.fda.gov
Positioner, Tooth, Preformed	KMY	1	Manufacturer	accessdata.fda.gov
Pusher, Band, Orthodontic	ECS	1	Manufacturer	accessdata.fda.gov
Retainer, Screw Expansion, Orthodontic	DYJ	1	Manufacturer	accessdata.fda.gov
Spring, Orthodontic	ECO	1	Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Repackager or relabeler	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
May 4, 2023	K222847	Ceramic Brackets Orthometric	NJM	Substantially Equivalent	Orthometric - Industria E Comercio DE Produtos Medicos	accessdata.fda.gov
October 3, 2013	K131042	LEDEX	EBZ	Substantially Equivalent	Dentmate Technology Co. , Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 4, 2023. 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.