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3M Unitek Transbond™ PLUS Color Change Adhesive - HSA Registration DE0010055

Access comprehensive regulatory information for 3M Unitek Transbond™ PLUS Color Change 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 DE0010055 and owned by 3M Unitek Corporation. The device was registered on September 04, 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
DE0010055
3M Unitek Transbond™ PLUS Color Change Adhesive
HSA Registration Number: DE0010055
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Product Description

Transbond PLUS Color Change Adhesive is designed for bonding ceramic and metal orthodontic brackets. Transbond PLUS Color Change Adhesive is not indicated for use with plastic (polycarbonate) brackets. Transbond PLUS Color Change Adhesive is not indicated for use with other orthodontic applications where the cured adhesive is exposed and not covered by appliances.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
HSA Product Code
HSAMDB00103
HS Code
33069000
Registration Information
Registration Number
DE0010055
Registration Date
September 04, 2012
Change Notification Approval Date
November 29, 2024
Retention Due Date
September 03, 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)
Transbond PLUS Color Change - Adhesive Syringe Kit (2ea/Kt) Transbond PLUS Color Change - Adhesive Capsule Kit (25 ea/Kt) Transbond PLUS Color Change - Adhesive Syringe Refill(4ea/Pk) Transbond PLUS Color Change - Adhesive Capsule Refill (25ea) Transbond PLUS Color Change - Adhesive Syringe Sample (1ea) Transbond PLUS Color Change - Adhesive Capsule Sample(2ea/Pk) Syringe kit with Transbond Plus Self Etching Primer Capsule kit with Transbond Plus Self Etching Primer
Model Identifier(s)
712-101 712-102 712-103 712-104 712-105 712-106 712-107 712-108