Singapore HSA registration DE0509604
3M™ Incognito™ Appliance System
Singapore·CLASS B·3M Unitek Corporation·Registered July 31, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0509604
- Registration Date
- July 31, 2024
- Change Notification Approval Date
- March 04, 2025
- Retention Due Date
- July 30, 2025
Product 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.
Product Owner
- Short Name
- 3M Unitek
- Address
- 3M Company, 2724 South Peck Road, Monrovia, California, 91016, UNITED STATES
Registrant
- Address
- 10 ANG MO KIO STREET 65, TECHPOINT, #01-01, SINGAPORE 569059
Importer
- Address
- 10 ANG MO KIO STREET 65, TECHPOINT, #03-01, SINGAPORE 569059 10 ANG MO KIO STREET 65, TECHPOINT, #03-01, SINGAPORE 569059 10 ANG MO KIO STREET 65, TECHPOINT, #01-01, SINGAPORE 569059 6 TAGORE DRIVE, TAGORE INDUSTRIAL BUILDING, #03-11, SINGAPORE 787623
Model information
- Model Name(s)
- 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(s)
- 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
About this record
Access comprehensive regulatory information for 3M™ Incognito™ Appliance System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509604 and owned by 3M Unitek Corporation. The device was registered on July 31, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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