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3M™ RelyX™ Universal Resin Cement - HSA Registration DE0508461

Access comprehensive regulatory information for 3M™ RelyX™ Universal Resin Cement in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508461 and owned by 3M Deutschland GmbH. The device was registered on September 06, 2023.

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
DE0508461
3M™ RelyX™ Universal Resin Cement
HSA Registration Number: DE0508461
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Product Description

Dental luting agent for cementation of indirect restorations. Use of RelyX Universal in Self-Adhesive Mode or in Adhesive Mode with Scotchbond Universal Plus for the Following Indications: • Final cementation of all-ceramic, composite, or metal inlays and onlays, crowns, and bridges • Final cementation of posts made of ceramic, glass fiber-reinforced composite or metal, and screws • Final cementation of all-ceramic, composite, or metal restorations on implant abutments. Use of RelyX Universal in Adhesive Mode with Scotchbond Universal Plus for the Following Indications: • Final cementation of all-ceramic or metal Maryland bridges and 3-unit inlay/onlay bridges • Final cementation of all-ceramic or composite veneers and occlusal veneers (tabletops). Scotchbond Universal Etchant is used for etching of enamel and dentin using the acid etching technique.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0508461
Registration Date
September 06, 2023
Change Notification Approval Date
October 30, 2024
Retention Due Date
September 05, 2025
Product Owner
Short Name
3M Deutschland GmbH
Address
Carl-Schurz-Straße 1, 41453 Neuss, GERMANY
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™ RelyX™ Universal Resin Cement - Sample Kit - TR 3M™ RelyX™ Universal Resin Cement - Sample Kit - A1 3M™ RelyX™ Universal Resin Cement - Trial Kit - TR 3M™ RelyX™ Universal Resin Cement - Trial Kit - A1 3M™ RelyX™ Universal Resin Cement - TR 3M™ RelyX™ Universal Resin Cement - A1 3M™ RelyX™ Universal Resin Cement - A3O 3M™ RelyX™ Universal Resin Cement - WO 3M™ RelyX™ Universal Micro Mixing Tips
Model Identifier(s)
56966 56967 56969 56970 56971 56972 56973 56974 56975