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3M™ Unitek™ Transbond™ IDB Pre-Mix Chemical Cure Adhesive - HSA Registration DE0010975

Access comprehensive regulatory information for 3M™ Unitek™ Transbond™ IDB Pre-Mix Chemical Cure Adhesive in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0010975 and owned by 3M Unitek Corporation. The device was registered on September 19, 2012.

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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CLASS B
DE0010975
3M™ Unitek™ Transbond™ IDB Pre-Mix Chemical Cure Adhesive
HSA Registration Number: DE0010975
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Product Description

Transbond IDB Adhesive is intended for use in orthodontic treatment of malocclusions (improper bite). It is used in bonding orthodontic appliances in order to convey physical force via wires and other modules, such as elastomeric ligatures and springs. Transbond IDB Adhesive is indicated for indirect bonding of orthodontic appliances to tooth surfaces for orthodontic treatment of malocclusion. Transbond IDB Adhesive is a system consisting of two parts (Part A and Part B) that cures via the chemical interaction of the curing agent in Part A and the activator in Part B.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
HSA Product Code
HSAMDB00103
HS Code
33069000
Registration Information
Registration Number
DE0010975
Registration Date
September 19, 2012
Change Notification Approval Date
November 29, 2024
Retention Due Date
September 18, 2025
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)
Disposable wells 96/pk Standard Applicators 100/pk Transbond IDB Pre-Mix Chemical Cure Adhesive Kit Transbond IDB Part A Resin Reorder Transbond IDB Part B Resin Reorder
Model Identifier(s)
712-023 712-092 712-120 712-121 712-122