Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009170227

FEI Number

3009170227

Entity Name

INDUSBELLO INDUSTRIA DE INSTRUMENTOS ODO

City/State/Country

Londrina Parana, BR

Establishment Address

Tereza de Souza Street, 171, Pq Indl. Kiugo Takata, Londrina Parana 86042-390, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Indusbello Ind. e Com. de Prod. Med. e Odont. Ltda. (Owner Number: 10036368)

Owner / Operator Contact Address

Tereza de Souza Street, 171, Pq Indl. Kiugo Takata, Londrina, BR-PR 86042-390, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

INDUSBELLO INDUSBELLO INDUSBELLO INDUSBELLO INDUSBELLO INDUSBELLO INDUSBELLO INDUSBELLO INDUSBELLO INDUSBELLO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2021-05-03
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2017-01-09
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2021-07-16
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2021-09-01
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2021-07-16
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2021-07-19
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2021-07-19
IWZ	Film, Radiographic	Radiology	Class 1	892.1840	2021-07-16
KCQ	Tube Impression And Matrix	Dental	Class 1	872.6570	2021-07-19
KAH	Microrule, Ent	Ear, Nose, Throat	Class 1	874.4420	2017-04-13

Official Correspondent

Luciano Marques

US Agent Details

Wen Wang Business: Willow Glen Consultancy LLC Email: Wen.Wang@WillowGlenFDA.com Phone: (619) 8690249

Related Public Records

Same Entity

Indusbello Ind. e Com. de Prod. Med. e Odont. Ltda.

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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04

Similar Registrations

Registration Number	Establishment Name	Location
1058726	RUMEX INTERNATIONAL CO.	Tampa, FL, US
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US
3008242564	Septodont, Inc	Lancaster, PA, US
3012507533	Integra Canada ULC	Oakville Ontario, CA
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009170227. Last updated year: 2026. Please use registration number 3009170227 when referencing this establishment in official correspondence.