Search Results

Multilink Automix is used for the permanent cementation of indirect restorations where a strong bond is desired:

• Inlays, onlays, crowns, bridges and root posts made of: –
  • o Metal and metal ceramics
  • o All-ceramics, in particular opaque zirconium oxide ceramics
  • o Composites and fibre-reinforced composites

Multilink Automix is a self-curing and self-etching luting composite system for the adhesive luting of indirect restorations made of metalceramic all-ceramic and composite. Multilink Automix is applied together with the selfetching and self-Ocuring Multilink Primer. Monobond Plus is recommended as a coupling agent to achieve a strong bond to precious and non-precious alloys, as well as to all ceramics made of zirconium and aluminum oxide and silicate ceramics.

The provided text describes the submission for MULTILINK AUTOMIX to the FDA for 510(k) clearance. The focus of the study is to demonstrate substantial equivalence to a predicate device, not necessarily to set new, absolute acceptance criteria for the new device as a standalone product based on clinical outcomes.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance of the predicate device, Multilink (K032470), as the new device, Multilink Automix, aims to show substantial equivalence. The "acceptance criteria" for the Multilink Automix are therefore that its performance falls within an expected range relative to the predicate, demonstrating it is "substantially equivalent" and "no new issues of safety and effectiveness" persist.

Ask a specific question about this device