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3R Indústria E Comércio LTDA

Brazil·BR-MF-000034808

Last updated September 17, 2026

What 3R Indústria E Comércio LTDA makes

3R Indústria E Comércio LTDA manufactures diamond-coated rotary dental burs packaged in boxes of ten, including variations such as standard, carbide-tipped, and fine-grit designs for precision cutting and shaping in dental procedures.

These Class I dental burs are listed in the EU’s eudamed registry, adhering to regulatory requirements for medical devices under Brazilian and European standards. The company is based in Brazil.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does 3R Indústria E Comércio LTDA manufacture?

3R Indústria E Comércio LTDA specializes in manufacturing diamond-coated rotary dental burs. These devices come in various designs, such as standard, carbide-tipped, and fine-grit variations, all packaged in boxes of ten. They are specifically used for precision cutting and shaping in dental procedures.

Where is 3R Indústria E Comércio LTDA based?

The company, 3R Indústria E Comércio LTDA, is based in Brazil. This geographical location influences the regulatory framework under which its devices are developed and marketed, including compliance with Brazilian and European standards.

Which regulatory registries list the devices manufactured by 3R Indústria E Comércio LTDA?

The devices produced by 3R Indústria E Comércio LTDA are listed in the eudamed registry, which is the European database for medical devices. Listing in eudamed is required for devices intended to be placed on the European market, ensuring transparency and traceability under EU regulations.

How are the dental burs manufactured by 3R Indústria E Comércio LTDA classified under medical device regulations?

The diamond-coated rotary dental burs from 3R Indústria E Comércio LTDA fall under Class I classification. This classification is determined based on their intended use and risk profile, where Class I devices are generally considered low-risk and subject to fewer regulatory controls than higher-risk categories.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Brazil
Address
290, R PTOLOMEU, Sao Paulo, Brazil
LinkedIn
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Facebook
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Phone
+55 11 5525.0590
PRRC Contact
Cátia Silva
EUDAMED SRN
BR-MF-000034808
FDA FEI Number
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DUNS Number
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Catalogue (653)

Page 14 of 14
DeviceModel / ReferenceRegistriesClassStatus
Polyester Matrix Band - C/ 100 Units. 10.411.001
EUDAMED
Class IActive
DIAMOND BUR 2128 - Box with 10 2128
EUDAMED
Class IActive
DIAMOND BUR 4114F - Box with 10 4114F
EUDAMED
Class IActive

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