Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006542438

FEI Number

3006542438

Entity Name

ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS

City/State/Country

LONDRINA Parana, BR

Establishment Address

101, WALDIR LANDGRAF, BAIRRO LINDOIA, LONDRINA Parana 86031-218, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ANGELUS INDUSTRIA DE PRODUTOS ODONTOLOGICOS (Owner Number: 9102422)

Owner / Operator Contact Address

101 Waldir Landgraf Street, Londrina, BR-PR 86031218, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201222

PMA Number

N/A

All Registered Proprietary Names

MTA - Fillapex BIO-C SEALER ION+ Interlig 3D MOLDEX Bite 3D MOLDEX AUTOCLAVABLE IMPRESSION TRAY MOLDEX 3 X 1 Nexis Endodontic Files Flex Endodontic Ejector Flex Kids Ejector Flex Surgical Ejector Flex Saliva Ejector MTA-FILLAPEX Dappen Ring Angie Syringe Cover Angelus Syringe Sleeve KIDS TRIPLE SYRINGE - PINK KIDS TRIPLE SYRINGE - BLUE Perma Fiber / Perma Mesh E-FIBER PERMA MESH MTA Applicator SPEED GUN METALPIN SILICON STOP ENDODONTIC RULER ENDOMETRIC INTERMEDIUM Bio-C Sealer STEEL DRILLS DISCLOSING AGENT MTA Repair HP MTA ANGELUS MTA ANGELUS Grey MTA ANGELUS White ENDO TIPS Triple Tips MTA-FILLAPEX MIXING TIPS BIO-C SEALER Tips Angie Prophy CONTACTO PAPER CONTACTO FILM CONTACTO ARCH CONTACTO ORTO BIO-C REPAIR ION+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2012-08-28
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2019-12-16
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2017-11-03
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2007-06-01
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2026-05-10
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2013-05-17
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2016-08-19
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2015-04-02
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	2012-08-15
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2013-05-20
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2017-11-03
EKI	Carrier, Amalgam, Operative	Dental	Class 1	872.4565	2013-05-08
EBL	Pin, Retentive And Splinting, And Accessory Instruments	Dental	Class 1	872.3740	2009-08-03
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2009-08-03
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2018-01-10
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2026-03-13
NYH	Plaque Disclosing Kit	Dental	Class 2	872.1740	2018-01-25
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2016-09-09
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2012-01-24
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2009-08-03
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2015-04-06
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2019-04-15
EFH	Paper, Articulation	Dental	Class 1	872.6140	2009-08-03
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2021-02-12

Official Correspondent

Sophia Stutz

US Agent Details

LILIAN LLULL Business: Senior Partner Email: lilian@techlinkusa.net Phone: (305) 2066777

Related Public Records

Same Entity

ANGELUS INDUSTRIA DE PRODUTOS ODONTOLOGICOS

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
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3003449480	VERICOM CO., LTD.	Chuncheon-Si Gangwon, KR
3030405669	ODNE AG	Dubendorf Zurich, CH
3031606505	ENPUNO BIOTECHNOLOGY CO., LTD	Changsha Hunan, CN
1032227	BRASSELER U.S.A. DENTAL, LLC	SAVANNAH, GA, US
9610964	SEPTODONT	CEDEX Val-de-Marne, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006542438. Last updated year: 2026. Please use registration number 3006542438 when referencing this establishment in official correspondence.