Manufacturer registered with FDA

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

Londrina, Brazil. Lists 8 dental device types with FDA across 1 registered establishment.

FDA owner/operator10036368Manufacturer
Device types listed
8
Brands and models
8
510(k) clearances
0as applicant
Markets registered in
1United States
Establishments
1Brazil

Devices listed with FDA

What Indusbello Ind. e Com. de Prod. Med. e Odont. Ltda. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Saliva Ejector MouthpieceDYN · Class 1—Maker
INDUSBELLO
2021
Polishing Agent StripEHM · Class 1Polishing & prophylaxisMaker
INDUSBELLO
2021
Preformed Impression TrayEHY · Class 1Impression traysMaker
INDUSBELLO
2021
All Types RetractorEIG · Class 1Dental hand instrumentsMaker
INDUSBELLO
2013
Dental Instrument HandleEJB · Class 1Dental hand instrumentsMaker
INDUSBELLO
2021
Cartridge SyringeEJI · Class 2Dental needles & syringesMaker
INDUSBELLO
2021
Tube Impression and MatrixKCQ · Class 1—Maker
INDUSBELLO
2021
Dental Stain EraserMAU · Class 1—Maker
INDUSBELLO
2021

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Registered establishments

EstablishmentLocationWhat it does
INDUSBELLO INDUSTRIA DE INSTRUMENTOS ODOFDA reg. 3009170227Londrina Parana, BrazilManufacturer

Other names on FDA records

Indusbello Industria de Instrumentos Odo

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10036368). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.