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™	017-891B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-757B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-630	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-4126	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-9100B	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-104	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-318	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-932	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-747	FDA UDI	Class I	Active
3M™ Unitek™	017-219B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-671	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5116	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-683B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6570	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-409	FDA UDI	Class I	Active
3M™ Unitek™	017-320	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-708	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-609	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-911B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-8120	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-414	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-9200	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-773	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-8200	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5846	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-7160	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5926	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-522	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ ZeroBase™	017-907	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-4476	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-679	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-884B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-744	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-768	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-687	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-621	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-337	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-433	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-890B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-908	FDA UDI	Class I	Active
3M™ Unitek™	017-316B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-457	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-697	FDA UDI	Class I	Active
3M™ Unitek™	017-320B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-775	FDA UDI	Class I	Active
3M™ Unitek™	017-205	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-3390	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-458	FDA UDI	Class I	Active
3M™ Unitek™	017-204B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-892B	FDA UDI	Class I	Active

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