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™	017-402B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-648	FDA UDI	Class I	Active
3M™ Unitek™	017-211B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-592B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ ZeroBase™	017-806	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-527	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-410	FDA UDI	Class I	Active
3M™ Unitek™	001-764	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-715	FDA UDI	Class I	Active
3M™ Unitek™	017-304	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5150	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-922	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-748	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-792B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-811B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-920B	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-338	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-686	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-767	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-8970	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-9220	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-136	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-142	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-7970	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-238	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-797B	FDA UDI	Class I	Active
3M™ Unitek™	017-251	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-829B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-439	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-420B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-921	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-8110	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-6840	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-602	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-688	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-505	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-684B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-414B	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-909	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-916	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™ MBT™	004-2480	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	017-878	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-407	FDA UDI	Class I	Active
3M™ Unitek™	001-333	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-869	FDA UDI	Class I	Active
3M™ Unitek™ SmartClip™	004-538	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-658	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-7166	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-5340	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™	017-419B	FDA UDI	Class I	Active

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