Question 1

What types of medical devices does 3M do Brasil Ltda. manufacture?

Accepted Answer

3M do Brasil Ltda. specializes in metal orthodontic brackets, which are used in fixed dental appliances to align teeth. Their portfolio includes standard brackets and specialized variants, such as those with SmartClip attachments, designed to improve precision in orthodontic treatments. These devices fall under the category of dental hardware.

Question 2

Where is 3M do Brasil Ltda. based, and what regulatory region does it operate in?

Accepted Answer

3M do Brasil Ltda. is based in the United States. As a manufacturer of Class I medical devices, their products are subject to U.S. regulatory oversight, including compliance with FDA requirements for dental orthodontic hardware. The company’s devices are listed in the FDA’s Unique Device Identification (UDI) database, ensuring traceability and regulatory transparency.

Question 3

Which regulatory registries or databases list the devices manufactured by 3M do Brasil Ltda.?

Accepted Answer

The devices produced by 3M do Brasil Ltda. are included in the FDA’s Unique Device Identification (UDI) database. This registry ensures that each product has a standardized identifier for tracking, compliance, and transparency in the medical device supply chain, particularly for Class I orthodontic brackets.

Question 4

How are the orthodontic brackets made by 3M do Brasil Ltda. classified under medical device regulations?

Accepted Answer

The orthodontic brackets manufactured by 3M do Brasil Ltda. are classified as Class I medical devices. This classification is typically assigned to low-risk devices where general controls alone are sufficient to ensure safety and effectiveness, such as in the case of dental hardware used for routine orthodontic alignment.

Device	Model / Reference	Registries	Class	Status
3M™ Unitek™ Victory Series™ ZeroBase™	017-625	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6936	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-877	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-682	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-426	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-404	FDA UDI	Class I	Active
3M™ Unitek™	017-221	FDA UDI	Class I	Active
3M™ Unitek™	017-233	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6150	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-408	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-421	FDA UDI	Class I	Active
3M™ Unitek™	017-305	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-407	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-413	FDA UDI	Class I	Active
3M™ Unitek™	017-338	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-568	FDA UDI	Class I	Active
3M™ Unitek™	017-323	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-515	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-793	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6840B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-8950	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-684	FDA UDI	Class I	Active
3M™ Unitek™	017-343	FDA UDI	Class I	Active
3M™ Unitek™	017-478	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-829	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-692B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5136	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-878B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-8090	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-517	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-790B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6990	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-588	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-918	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-759	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-584B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-529B	FDA UDI	Class I	Active
3M™ Unitek™	017-313B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-895B	FDA UDI	Class I	Active
3M™ Unitek™	001-310	FDA UDI	Class I	Active
3M™ Unitek™	017-240	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-777	FDA UDI	Class I	Active
3M™ Unitek™	001-329	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5306	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-659	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-926	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5036	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-207	FDA UDI	Class I	Active
3M™ Unitek™	001-376	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-765	FDA UDI	Class I	Active

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