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™	017-671B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-599B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-883	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-310	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-715B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-586B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-831	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-872B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-548	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-714	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ ZeroBase™	017-728	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-403B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-591	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-522B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-515B	FDA UDI	Class I	Active
3M™ Unitek™	017-392	FDA UDI	Class I	Active
3M™ Unitek™	017-237	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-657	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-8100	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-925	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-3500	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-108	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-876B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-401B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-776B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-913	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-542	FDA UDI	Class I	Active
3M™ Unitek™	001-361	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-247	FDA UDI	Class I	Active
3M™ Unitek™	001-337	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-502B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-791	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-594	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-7980	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-896	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-864	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-760	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-898B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-9130	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-443	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-698	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-425	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-210	FDA UDI	Class I	Active
3M™ Unitek™	017-309B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-925B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-772	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-586	FDA UDI	Class I	Active
3M™ Unitek™	017-344	FDA UDI	Class I	Active
3M™ Unitek™	017-332	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-589B	FDA UDI	Class I	Active

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