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3M UNITEK CORPORATION

Last updated May 24, 2026

What 3M UNITEK CORPORATION makes

3M Unitek Corporation manufactures orthodontic products including metal and ceramic brackets, tubes, archwires, and metal bands. The company also produces progressive aligners, orthodontic pliers, and appliance relief materials.

These devices are classified as Class I and Class II medical devices and are listed in the FDA UDI database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of products does 3M Unitek Corporation manufacture?

3M Unitek Corporation specializes in the production of orthodontic equipment. Their product range includes metal and ceramic orthodontic brackets, orthodontic tubes, archwires, and metal bands. Additionally, the company manufactures orthodontic progressive aligners, specialized pliers, and appliance relief materials to support clinical orthodontic procedures.

Where is 3M Unitek Corporation based?

3M Unitek Corporation is based in the United States. This location serves as the primary base for the company's operations and the manufacturing of its orthodontic product lines.

How are the devices from 3M Unitek Corporation classified?

The medical devices manufactured by 3M Unitek Corporation are classified as either Class I or Class II devices. This classification system is used to determine the level of regulatory oversight required based on the risk profile and intended use of the specific orthodontic products.

Where can I find information regarding the registration of these devices?

The devices manufactured by 3M Unitek Corporation are listed in the FDA UDI database. This registry provides transparency and tracking for medical devices, ensuring that the company's products are documented according to regulatory requirements for unique device identification.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: mmm.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)423-4588
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 008256356

Catalogue (8379)

Page 9 of 168

Device	Model / Reference	Registries	Class	Status
Unitek™ Gemini Clear	117-104	FDA UDI	Class II	Active
3M™ Unitek™	485-004	FDA UDI	Class I	Active
3M™ AlastiK™	406-916	FDA UDI	Class I	Active
3M™ AlastiK™	406-233	FDA UDI	Class I	Active
APC™ II Unitek™ Gemini	3119-142	FDA UDI	Class II	Active
APC™ PLUS Unitek™ Miniature Twin V-Slot	5017-338	FDA UDI	Class II	Active
3M™ AlastiK™	406-679	FDA UDI	Class I	Active
APC™ PLUS Victory Series™ Low Profile	5024-809	FDA UDI	Class II	Active
APC™ PLUS Victory Series™	5017-6590	FDA UDI	Class II	Active
3M™ Victory Series™	905-218	FDA UDI	Class I	Active
3M™ Unitek™ Uni-Twin™	020-855	FDA UDI	Class I	Active
3M™ Victory Series™	901-408	FDA UDI	Class I	Active
APC™ Flash-Free Clarity™ ADVANCED	4006-172	FDA UDI	Class II	Active
APC™ PLUS Unitek™ Miniature Twin	5017-378	FDA UDI	Class II	Active
APC™ II SmartClip™ SL3	3004-513	FDA UDI	Class II	Active
APC™ II Victory Series™	3017-719	FDA UDI	Class II	Active
3M™ Unitek™	4300-025	FDA UDI	Class I	Active
APC™ PLUS Unitek™ Miniature Twin	5017-106	FDA UDI	Class II	Active
3M™ Victory Series™	955-108	FDA UDI	Class I	Active
3M™ Unitek™	300-793	FDA UDI	Class I	Active
APC™ Flash-Free Clarity™ ADVANCED	4006-206	FDA UDI	Class II	Active
3M™ Unitek™ Victory Series™ MBT™	069-3203	FDA UDI	Class I	Active
APC™ Flash-Free SmartClip™ SL3	4004-5270	FDA UDI	Class II	Active
APC™ II Victory Series™	3066-5024	FDA UDI	Class II	Active
3M™ AlastiK™	406-975	FDA UDI	Class I	Active
3M™ AlastiK™	406-222	FDA UDI	Class I	Active
APC™ II SmartClip™ SL3	3004-413	FDA UDI	Class II	Active
APC™ II Victory Series™ Low Profile	3024-791	FDA UDI	Class II	Active
APC™ II SmartClip™ SL3	3004-2400	FDA UDI	Class II	Active
3M™ Unitek™	145-114	FDA UDI	Class I	Active
3M™ Unitek™ Uni-Twin™	020-853	FDA UDI	Class I	Active
3M™ Unitek™	341-111	FDA UDI	Class I	Active
APC™ II Unitek™ Mini Uni-Twin	3020-195	FDA UDI	Class II	Active
APC™ II Unitek™ Gemini	3027-220	FDA UDI	Class II	Active
3M™ AlastiK™	406-309	FDA UDI	Class I	Active
APC™ II Victory Series™	3017-647	FDA UDI	Class II	Active
3M™ SmartClip™ Dimpled Nitinol Super-Elastic OrthoForm™	9296-405	FDA UDI	Class I	Active
3M™ Unitek™ Victory Series™ MBT™	024-874	FDA UDI	Class I	Active
3M™ Unitek™ Uni-Twin™	020-453	FDA UDI	Class I	Active
3M™ Unitek™	9297-955	FDA UDI	Class I	Active
3m™	9293-854	FDA UDI	Class I	Active
Clarity™ ADVANCED	006-107	FDA UDI	Class II	Active
3M™ Unitek™	4297-604	FDA UDI	Class I	Active
3M™ Victory Series™	953-172	FDA UDI	Class I	Active
3M™ Victory Series™	905-113	FDA UDI	Class I	Active
3M™ Victory Series™	902-262	FDA UDI	Class I	Active
APC™ Flash-Free Clarity™ ADVANCED	4006-309	FDA UDI	Class II	Active
APC™ PLUS Victory Series™	5068-8982	FDA UDI	Class II	Active
3M™ Clarity™	358-509	FDA UDI	Class II	Active
APC™ PLUS Victory Series™	5017-6890	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

There is one recall record for 3M Unitek Corporation initiated on 2024-11-26. The status of this record is listed as open and classified. The reason provided for the recall is an increase of complaints regarding bracket bond failures and skin irritation or blistering.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Nov 26, 2024	Z-0797-2025	—	open, classified	Due to an increase of complaints for bracket bond failures and skin irritation or blistering.