Data / Medical devices / Brazil / Angelus Industria De Productos Odontologicos

Angelus Industria De Productos Odontologicos: FDA-registered device maker in LONDRINA Parana, Brazil, 11 510(k) clearances

Name: Angelus Industria De Productos Odontologicos FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Angelus Industria De Productos Odontologicos is registered with the FDA (registration 3006542438) in LONDRINA Parana, Brazil. It lists 21 device types. The FDA files 11 510(k) clearances under its listings, the newest dated February 11, 2021. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Angelus Industria De Productos Odontologicos

FDA registration number: 3006542438
Address: 101, Waldir Landgraf Bairro Lindoia, LONDRINA Parana, Brazil, 86031-218
Owner or operator: ANGELUS INDUSTRIA DE PRODUTOS ODONTOLOGICOS (9102422)
Roles: Exporter to the US, Manufacturer, Specification developer
First device listed: June 1, 2007
Registered through: 2026
Brand names listed: 3D MOLDEX, 3D MOLDEX Bite, AUTOCLAVABLE IMPRESSION TRAY, Angelus Syringe Sleeve, Angie Prophy, Angie Syringe Cover, BIO-C REPAIR, BIO-C REPAIR ION+ and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Specification developer	accessdata.fda.gov
Adaptor, Holder, Syringe	IQG	1	Manufacturer	accessdata.fda.gov
Carrier, Amalgam, Operative	EKI	1	Manufacturer	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Manufacturer	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Manufacturer	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Manufacturer	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	1	Manufacturer	accessdata.fda.gov
Frame, Rubber Dam	EJE	1	Manufacturer	accessdata.fda.gov
Gauge, Depth, Instrument, Dental	EIL	1	Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Manufacturer	accessdata.fda.gov
Mouthpiece, Saliva Ejector	DYN	1	Manufacturer	accessdata.fda.gov
Paper, Articulation	EFH	1	Manufacturer	accessdata.fda.gov
Pin, Retentive And Splinting, And Accessory Instruments	EBL	1	Manufacturer	accessdata.fda.gov
Plaque Disclosing Kit	NYH	2	Manufacturer	accessdata.fda.gov
Post, Root Canal	ELR	1	Manufacturer	accessdata.fda.gov
Protector, Dental	BRW	1	Manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Resin, Root Canal Filling	KIF	2	Manufacturer	accessdata.fda.gov
Syringe, Periodontic, Endodontic, Irrigating	EIC	1	Manufacturer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Manufacturer	accessdata.fda.gov
Unit, Syringe, Air And/Or Water	ECB	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
February 11, 2021	K201222	Bio-C Repair Ion+	KIF	Substantially Equivalent	Angelus Industria DE Produtos Odontologicos S/A	accessdata.fda.gov
December 12, 2019	K190537	BIO-C Sealer Ion+	KIF	Substantially Equivalent	Angelus Industria DE Produtos Odontologicos S/A	accessdata.fda.gov
January 4, 2019	K180199	BIO-C TEMP	KIF	Substantially Equivalent	Angelus Industria DE Produtos Odontologicos S/A	accessdata.fda.gov
August 31, 2018	K180185	BIO-C REPAIR	KIF	Substantially Equivalent	Angelus Industria DE Produtos Odontologicos S/A	accessdata.fda.gov
January 4, 2018	K172701	BIO-C SEALER	KIF	Substantially Equivalent	Angelus Industria DE Produtos Odontologicos S/A	accessdata.fda.gov
August 31, 2016	K151047	MTA Repair HP	KIF	Substantially Equivalent	Angelus Industria DE Productos Odontologicos	accessdata.fda.gov
April 25, 2014	K140247	MTA FILLAPEX	KIF	Substantially Equivalent	Angelus Industria DE Productos Odontologicos SA	accessdata.fda.gov
May 31, 2013	K123823	INTERLIG	EBF	Substantially Equivalent	Angelus Industria DE Productos Odontologicos	accessdata.fda.gov
August 21, 2012	K113568	MTA-FILLAPEX	KIF	Substantially Equivalent	Paxmed International	accessdata.fda.gov
January 6, 2012	K112046	MTA ANGELUS	KIF	Substantially Equivalent	Angelus Industria DE Productos Odontologicos	accessdata.fda.gov
December 17, 2008	K082180	PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440	EBI	Substantially Equivalent	Angelus Industria DE Productos Odontologicos	accessdata.fda.gov

Compare with other makers

Updated February 11, 2021. 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.