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™	004-509	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-716B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-570	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-6044	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-896B	FDA UDI	Class I	Active
3M™ Unitek™	017-303	FDA UDI	Class I	Active
3M™ Unitek™	017-333	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-332	FDA UDI	Class I	Active
3M™ Unitek™	001-309	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ ZeroBase™	017-807	FDA UDI	Class I	Active
3M™ Unitek™	017-219	FDA UDI	Class I	Active
3M™ Unitek™	017-224	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-528	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-884	FDA UDI	Class I	Active
3M™ Unitek™	017-337	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-796	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-106	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-446	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-910	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-131	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-745	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ ZeroBase™	017-905	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-504B	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-529	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-826	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5830B	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-432	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5940	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-7020	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-211	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-541	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-561	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-923	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-102	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-7570	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6146	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-424	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-519B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-562	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-536	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-9320	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-650	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-501	FDA UDI	Class I	Active
3M™ Unitek™	017-206	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-215	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-705	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-771	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-664	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-895	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-746	FDA UDI	Class I	Active

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