Data / Medical devices / Brazil / Dental Morelli Ltda.

Dental Morelli Ltda.: FDA-registered device maker in SOROCABA Sao Paulo, Brazil, 2 510(k) clearances

Name: Dental Morelli Ltda. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dental Morelli Ltda. is registered with the FDA (registration 9681207) in SOROCABA Sao Paulo, Brazil. It lists 25 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 8, 2014. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9681207
FEI number: 3001682269
Address: Alameda Jundiai,230/250 Jd.saira, SOROCABA Sao Paulo, Brazil, 18085.090
Owner or operator: DENTAL MORELLI LTDA. (9020620)
Roles: Manufacturer
First device listed: October 13, 2000
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Band, Elastic, Orthodontic	ECI	1	Manufacturer	accessdata.fda.gov
Band, Material, Orthodontic	DYO	1	Manufacturer	accessdata.fda.gov
Bar, Preformed	EHO	1	Manufacturer	accessdata.fda.gov
Bracket, Ceramic, Orthodontic	NJM	2	Manufacturer	accessdata.fda.gov
Bracket, Metal, Orthodontic	EJF	1	Manufacturer	accessdata.fda.gov
Clamp, Wire, Orthodontic	ECN	1	Manufacturer	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Manufacturer	accessdata.fda.gov
Facebow	KCR	1	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Orthodontic	OAT	2	Manufacturer	accessdata.fda.gov
Instrument, Ligature Tucking, Orthodontic	ECP	1	Manufacturer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Manufacturer	accessdata.fda.gov
Plier, Orthodontic	JEX	1	Manufacturer	accessdata.fda.gov
Point, Abrasive	EHL	1	Manufacturer	accessdata.fda.gov
Pusher, Band, Orthodontic	ECS	1	Manufacturer	accessdata.fda.gov
Retainer, Screw Expansion, Orthodontic	DYJ	1	Manufacturer	accessdata.fda.gov
Retractor, All Types	EIG	1	Manufacturer	accessdata.fda.gov
Scraper, Tongue	LCN	1	Manufacturer	accessdata.fda.gov
Setter, Band, Orthodontic	ECR	1	Manufacturer	accessdata.fda.gov
Spring, Orthodontic	ECO	1	Manufacturer	accessdata.fda.gov
Strip, Polishing Agent	EHM	1	Manufacturer	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Manufacturer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Manufacturer	accessdata.fda.gov
Tube, Orthodontic	DZD	1	Manufacturer	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	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
January 8, 2014	K130476	ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE	OAT	Substantially Equivalent	Dental Morelli	accessdata.fda.gov
August 27, 2013	K131197	EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS	NJM	Substantially Equivalent	Dental Morelli	accessdata.fda.gov

Compare with other makers

Updated January 8, 2014. 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.