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™	017-302	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-526	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-420	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-7020B	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-413	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-518	FDA UDI	Class I	Active
3M™ Unitek™	017-223	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-334	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-2470	FDA UDI	Class I	Active
3M™ Unitek™	017-208	FDA UDI	Class I	Active
3M™ Unitek™	017-389	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-311	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-828	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-814	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-910B	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-5290	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-7960	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-406	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-403	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-7033	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-107	FDA UDI	Class I	Active
3M™ Unitek™	017-352	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6590	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-612	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-981	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-2400	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-816B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5920	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-501B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-4320	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-333	FDA UDI	Class I	Active
3M™ Unitek™	017-218B	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-101	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-406	FDA UDI	Class I	Active
3M™ Unitek™	017-316	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-571	FDA UDI	Class I	Active
3M™ Unitek™	017-490	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5016	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-578	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6860	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-824	FDA UDI	Class I	Active
3M™ Unitek™	001-623	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-147	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5310	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-4036	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-772B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ ZeroBase™	017-726	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-415B	FDA UDI	Class I	Active
3M™ Unitek™	017-218	FDA UDI	Class I	Active
3M™ Unitek™	001-617	FDA UDI	Class I	Active

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