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HSA · registration DE0509604

3M™ Incognito™ Appliance System

SingaporeDentalClass B3M Unitek Corporation
Verified
Official record identity
Registration number
DE0509604
Model name
Incognito Appliance System Herbst Set; Incognito Appliance System Wire SS .016 Round; Incognito Appliance System Wire SS .016 X .022; Incognito Appliance System Wire SS .016 X .022 Extra Torque; Incognito Appliance System Wire SS .016 X .024; Incognito Appliance System Wire SS .016 X .024 Extra Torque; Incognito Appliance System Wire SS .018 Round; Incognito Appliance System Wire SS .018 X .025; Incognito Appliance System Wire SS .018 X .025 Reduced; Incognito Appliance System Wire Beta III Titanium .016 Round; Incognito Appliance System Wire Beta III Titanium .0175 X .0175; Incognito Appliance System Wire Beta III Titanium .017 X .025; Incognito Appliance System Wire TMA .0182 X .0182; Incognito Appliance System Wire Beta III Titanium .0182 X .025; Incognito Appliance System Wire SE NiTi .012 Round; Incognito Appliance System Wire SE NiTi .014 Round; Incognito Appliance System Wire SE NiTi .016 Round; Incognito Appliance System Wire SE NiTi .018 Round; Incognito Appliance System Wire SE NiTi .016 X .022; Incognito Appliance System Wire SE NiTi .017 X .025; Incognito Appliance System Wire SE NiTi .018 X .025
Model identifier
358-209; 358-238; 358-239; 358-240; 358-241; 358-242; 358-243; 358-244; 358-245; 358-246; 358-247; 358-248; 358-249; 358-250; 358-251; 358-252; 358-253; 358-254; 358-255; 358-256; 358-257
Registration date
July 31, 2024
Source update date
March 04, 2025
Classification
Risk class
Class B
Official value: CLASS B
Published category
Dental
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Published parties
Product owner
3M Unitek Corporation
Registrant / registration holder
KCI MEDICAL ASIA PTE. LTD.
Official description

The Incognito Appliance System is intended for use in orthodontic treatment of misaligned teeth. The lingual device is affixed to a tooth so that as pressure is exerted on the tooth the position of the tooth is altered.

Additional source fields
Product owner address
3M Company, 2724 South Peck Road, Monrovia, California, 91016, United States
Registrant address
10 ANG MO KIO STREET 65, #01-01, TECHPOINT, Singapore 569059
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.