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HSA · registration DE0508461

3M™ RelyX™ Universal Resin Cement

SingaporeDentalClass B3M Deutschland GmbH
Official record identity
Registration number
DE0508461
Model name
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
56966; 56967; 56969; 56970; 56971; 56972; 56973; 56974; 56975
Registration date
September 06, 2023
Source update date
March 18, 2024
Classification
Risk class
Class B
Official value: CLASS B
Published category
Dental
Published parties
Registrant / registration holder
KCI MEDICAL ASIA PTE. LTD.
Official 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.

Additional source fields
Product owner address
Carl-Schurz-Straße 1, 41453 Neuss, Germany
Registrant address
10 ANG MO KIO STREET 65, #01-01, TECHPOINT, Singapore 569059
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.