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3M™ ESPE Dental Restorative Materials - HSA Registration DE0500317

Access comprehensive regulatory information for 3M™ ESPE Dental Restorative Materials in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500317 and owned by 3M ESPE Dental Products. The device was registered on June 03, 2015.

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
DE0500317
3M™ ESPE Dental Restorative Materials
HSA Registration Number: DE0500317
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Product Description

Liquid compounds specially designed to fill dental cavities, restore damaged dental tissues, or for inlays, onlays and veneering. It includes accessories that are used specifically with the materials. It includes accessories e.g. mixing pad, dispenser and other components required to complete the restorative procedure. It does not include obturation of root canal.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
HSA Product Code
HSAMDB00103
HS Code
30064010
Registration Information
Registration Number
DE0500317
Registration Date
June 03, 2015
Change Notification Approval Date
April 04, 2025
Retention Due Date
June 02, 2025
Product Owner
Short Name
3M ESPE
Address
2510 Conway Avenue, St Paul, MN 55144-1000 USA, 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
Model Information
Model Name(s)
Filtek Bulk Fill Flowable Dispensing Tips Filtek™ Bulk Fill Flowable Restorative A1 Shade Syringe Filtek™ Bulk Fill Flowable Restorative A2 Shade Syringe Filtek™ Bulk Fill Flowable Restorative A3 Shade Syringe Filtek™ Bulk Fill Flowable Restorative Universal Shade Syringe Filtek Bulk Fill Flowable Restorative Universal Shade Syringe Restorative Dispenser
Model Identifier(s)
3740T 4862A1 4862A2 4862A3 4862U 4862U-S 5707SD