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3M™ Filtek™ Easy Match Universal Restorative - HSA Registration DE0509334

Access comprehensive regulatory information for 3M™ Filtek™ Easy Match Universal 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 DE0509334 and owned by 3M ESPE Dental Products. The device was registered on May 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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CLASS B
DE0509334
3M™ Filtek™ Easy Match Universal Restorative
HSA Registration Number: DE0509334
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Product Description

Intended use: A dental composite resin for anterior and posterior restorations. Indications for use: 3M Filtek Easy Match universal restorative is indicated for use in: · Direct anterior and posterior restorations (including occlusal surfaces) · Core Build‑ups

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0509334
Registration Date
May 31, 2024
Change Notification Approval Date
December 31, 2024
Retention Due Date
May 30, 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)
3M™ Filtek™ Easy Match Universal Restorative Value Pack (Capsule) 3M™ Filtek™ Easy Match Universal Restorative – Bright Shade (Capsule) 3M™ Filtek™ Easy Match Universal Restorative Intro Kit (Capsule) 3M™ Filtek™ Easy Match Universal Restorative – Natural Shade (Capsule) 3M™ Filtek™ Easy Match Universal Restorative Sample Pack (Capsule) 3M™ Filtek™ Easy Match Universal Restorative – Warm Shade (Capsule) 3M™ Filtek™ Easy Match Universal Restorative Value Pack (Syringe) 3M™ Filtek™ Easy Match Universal Restorative – Bright Shade (Syringe) 3M™ Filtek™ Easy Match Universal Restorative Intro Kit (Syringe) 3M™ Filtek™ Easy Match Universal Restorative – Natural Shade (Syringe) 3M™ Filtek™ Easy Match Universal Restorative Sample Pack (Syringe) 3M™ Filtek™ Easy Match Universal Restorative – Warm Shade (Syringe)
Model Identifier(s)
6410 6410B 6410K 6410N 6410S 6410W 6420 6420B 6420K 6420N 6420S 6420W