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™ SmartClip™ MBT™	004-128	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6156	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-533	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-665	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-598	FDA UDI	Class I	Active
3M™ Unitek™	017-222	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-611	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-2420	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-405	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-518	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-3470	FDA UDI	Class I	Active
3M™ Unitek™	017-321	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5880	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-593	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-436	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-512	FDA UDI	Class I	Active
3M™ Unitek™	017-301	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ ZeroBase™	017-805	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-874	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-770	FDA UDI	Class I	Active
3M™ Unitek™	001-534	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-521	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-699	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-662B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-610	FDA UDI	Class I	Active
3M™ Unitek™	017-1041	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-915	FDA UDI	Class I	Active
3M™ Unitek™	017-339	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-810	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-881	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6900	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ ZeroBase™	017-626	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ ZeroBase™	017-696	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-815B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-775B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-670	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-506	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-9110	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-643	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-683	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-231	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-8280	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-146	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-303	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-928	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-804	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-4330	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-411	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-440	FDA UDI	Class I	Active
3M™ Unitek™	001-523	FDA UDI	Class I	Active

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