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™	017-427	FDA UDI	Class I	Active
3M™ Unitek™	017-303B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6890	FDA UDI	Class I	Active
3M™ Unitek™	017-202	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-336	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-660	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-823	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-762	FDA UDI	Class I	Active
3M™ Unitek™	017-309	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-616B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-608	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5930	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-530	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-513B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-435	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-691	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-681	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-576	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-519	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-425	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-9080	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-622	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-556	FDA UDI	Class I	Active
3M™ Unitek™	017-1061	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-776	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-729	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-898	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-4150	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-341	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-2390	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-441	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-558	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-778	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-547	FDA UDI	Class I	Active
3M™ Unitek™	017-319B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-662	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-412	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-9110B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-883B	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-502	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-693	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-920	FDA UDI	Class I	Active
3M™ Unitek™	017-302B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-540	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-2150	FDA UDI	Class I	Active
3M™ Unitek™	017-104	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-234	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-798B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-657B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-583B	FDA UDI	Class I	Active

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