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™	017-5296	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-342	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-419	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-825	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-894	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-527	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-237	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-9330	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-572	FDA UDI	Class I	Active
3M™ Unitek™	017-491	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-434	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-983	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-871B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-774B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-4150B	FDA UDI	Class I	Active
3M™ Unitek™	017-203B	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-5250	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-134	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-904	FDA UDI	Class I	Active
3M™ Unitek™	017-120	FDA UDI	Class I	Active
3M™ Unitek™	017-311	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-714B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-893	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-144	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-808B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-811	FDA UDI	Class I	Active
3M™ Unitek™	017-306	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-6022	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-127	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5046	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-897B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-403	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-516	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-331	FDA UDI	Class I	Active
3M™ Unitek™	017-242	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-7150	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-933	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-680	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-924	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-214	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-534	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-589	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ ZeroBase™	017-727	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-706	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6850	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-603	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-877B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-507	FDA UDI	Class I	Active
3M™ Unitek™	017-1121	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-809	FDA UDI	Class I	Active

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