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™ MBT™	017-8130	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-689	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-4340	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-9290	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-4016	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-557	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-430	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6160	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-903	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-511	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-203	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-7950	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-875	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ ZeroBase™	017-695	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-242	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-312	FDA UDI	Class I	Active
3M™ Unitek™	017-249B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-983B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-817	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-813	FDA UDI	Class I	Active
3M™ Unitek™	001-334	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-431B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-763	FDA UDI	Class I	Active
3M™ Unitek™	017-208B	FDA UDI	Class I	Active
3M™ Unitek™	017-211	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-4046	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-523	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-825B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-646	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-645	FDA UDI	Class I	Active
3M™ Unitek™	017-240B	FDA UDI	Class I	Active
3M™ Unitek™	017-315	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-2490	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-427	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-7011	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-513	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-501	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ ZeroBase™	017-595	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-524	FDA UDI	Class I	Active
3M™ Unitek™	017-238	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-817B	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-7022	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5196	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-436	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-897	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-4290	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-534	FDA UDI	Class I	Active
3M™ Unitek™	017-477	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-2500	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-208	FDA UDI	Class I	Active

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