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™	017-492	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-503	FDA UDI	Class I	Active
3M™ Unitek™	017-121	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-564	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-532	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-579	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ ZeroBase™	017-906	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-8290	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-757	FDA UDI	Class I	Active
3M™ Unitek™	017-307	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-240	FDA UDI	Class I	Active
3M™ Unitek™	017-307B	FDA UDI	Class I	Active
3M™ Unitek™	017-250	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-409	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-209	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-438	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-585B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-777B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6850B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-8910	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-716	FDA UDI	Class I	Active
3M™ Unitek™	017-217	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-509	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-347	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-130	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-7140	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5900	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-892	FDA UDI	Class I	Active
3M™ Unitek™	017-479	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-421	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-764	FDA UDI	Class I	Active
3M™ Unitek™	017-215	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-703	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-773B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-575	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-432	FDA UDI	Class I	Active
3M™ Unitek™	017-133	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-605	FDA UDI	Class I	Active
3M™ Unitek™	017-216	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-212	FDA UDI	Class I	Active
3M™ Unitek™	017-112	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-912	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-812	FDA UDI	Class I	Active
3M™ Unitek™	017-202B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-430B	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-539	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6830B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-451	FDA UDI	Class I	Active
3M™ Unitek™	017-243	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-423	FDA UDI	Class I	Active

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