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™	017-391	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-603B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-694	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-620	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-233	FDA UDI	Class I	Active
3M™ Unitek™	017-331	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-2170	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-301	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-876	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-339	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-984	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-798	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-647	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-797	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-508	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-8960	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-613	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-875B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-601	FDA UDI	Class I	Active
3M™ Unitek™	017-241	FDA UDI	Class I	Active
3M™ Unitek™	017-252	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-597	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-672B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-536	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-431	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-929B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-402	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6856	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-431	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-416	FDA UDI	Class I	Active
3M™ Unitek™	017-232	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-538	FDA UDI	Class I	Active
3M™ Unitek™	017-201B	FDA UDI	Class I	Active
3M™ Unitek™	017-301B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-780	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-313	FDA UDI	Class I	Active
3M™ Unitek™	017-244	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6940	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-552	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-890	FDA UDI	Class I	Active
3M™ Unitek™	017-231	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-411	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-565	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-820	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-302	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-580	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-871	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-7480	FDA UDI	Class I	Active
3M™ Unitek™	017-390	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-423	FDA UDI	Class I	Active

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