Singapore HSA registration DE0019434

3M™ Filtek™ One Bulk Fill Restorative

Singapore·CLASS B·3M ESPE Dental Products·Registered July 25, 2017

Device classification

Device Class: CLASS B
Medical Speciality Area: Dental

Registration information

Registration Number: DE0019434
Registration Date: July 25, 2017
Change Notification Approval Date: December 31, 2024
Retention Due Date: July 24, 2025

Product description

Filtek One Bulk Fill Restorative is indicated for use in: • Direct anterior and posterior restorations (including occlusal surfaces) • Base/liner under direct restorations • Core build-ups • Splinting • Indirect restorations including inlays, onlays and veneers • Restorations of deciduous teeth • Extended fissure sealing in molars and premolars • Repair of defects in porcelain restorations, enamel, and temporaries

Product Owner

Name: 3M ESPE Dental Products
Short Name: 3M ESPE
Address: 2510 Conway Avenue, St Paul, MN 55144-1000 USA, UNITED STATES

Registrant

Name: KCI MEDICAL ASIA PTE. LTD.
Address: 10 ANG MO KIO STREET 65, TECHPOINT, #01-01, SINGAPORE 569059

Importer

Name: 3M INNOVATION SINGAPORE PTE LTD 3M TECHNOLOGIES (S) PTE. LTD. KCI MEDICAL ASIA PTE. LTD.
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): 3M™ Filtek™ One Bulk Fill Restorative 3M™ Filtek™ One Bulk Fill Restorative - A1 3M™ Filtek™ One Bulk Fill Restorative - A2 3M™ Filtek™ One Bulk Fill Restorative 3M™ Filtek™ One Bulk Fill Restorative - A3 3M™ Filtek™ One Bulk Fill Restorative - A3.5 3M™ Filtek™ One Bulk Fill Restorative - B1 3M™ Filtek™ One Bulk Fill Restorative - C2 3M™ Filtek™ One Bulk Fill Restorative - W 3M™ Filtek™ One Bulk Fill Restorative 3M™ Filtek™ One Bulk Fill Restorative - A1 3M™ Filtek™ One Bulk Fill Restorative - A2 3M™ Filtek™ One Bulk Fill Restorative 3M™ Filtek™ One Bulk Fill Restorative - A3 3M™ Filtek™ One Bulk Fill Restorative - A3.5 3M™ Filtek™ One Bulk Fill Restorative - B1 3M™ Filtek™ One Bulk Fill Restorative - C2 3M™ Filtek™ One Bulk Fill Restorative - W
Model Identifier(s): 4868-SP 4868A1 4868A2 4868A2-S 4868A3 4868A3.5 4868B1 4868C2 4868W 4869-CP 4869A1 4869A2 4869A2-S 4869A3 4869A3.5 4869B1 4869C2 4869W

About this record

Access comprehensive regulatory information for 3M™ Filtek™ One Bulk Fill Restorative in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0019434 and owned by 3M ESPE Dental Products. The device was registered on July 25, 2017.

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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