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™	017-209	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-676	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-720	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-661B	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-201	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-3150	FDA UDI	Class I	Active
3M™ Unitek™	017-340	FDA UDI	Class I	Active
3M™ Unitek™	017-489	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-440	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-582	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-437	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-3420	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-401	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-5270	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-408	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-515	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-927	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-827	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6870	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-619	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-567	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-649	FDA UDI	Class I	Active
3M™ Unitek™	017-379	FDA UDI	Class I	Unknown
3M™ Unitek™ Victory Series™	017-5830	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5860	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-410	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-873	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-761	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-120	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-707	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-504	FDA UDI	Class I	Active
3M™ Unitek™	017-114	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5870	FDA UDI	Class I	Active
3M™ Unitek™	017-318	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-447	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5990	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-433B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-792	FDA UDI	Class I	Active
3M™ Unitek™	017-220B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-690	FDA UDI	Class I	Active
3M™ Unitek™	001-375	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-614	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-9090	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-718	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-832	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-7146	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-213	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-218	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-6011	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-539	FDA UDI	Class I	Active

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