LogoFDA 510(k) Search
K Number
K061781
Device Name
MULTILINK SPRINT
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2006-09-05

(71 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Multilink Sprint is a self-adhesive, dual curing luting composite for the permanent cementation of direct restorations made of:

  • Metal and metal-ceramic (inlays, onlays, crowns, bridges and posts) .
  • High-strength all ceramic: zirconiumoxide-, Lithiumdisilicate and . Aluminum oxide ceramic (crowns, bridges, and posts)
  • Fiber-enforced composites (posts:) .
Device Description

Multilink Sprint is a self-adhesive, dual curing luting composite.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental cement called "Multilink Sprint." It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter primarily:

  • Confirms that the device is substantially equivalent to legally marketed predicate devices.
  • Outlines general regulatory requirements the manufacturer must comply with.
  • Lists the "Indications for Use" for the Multilink Sprint, which specify the types of restorations it can permanently cement.

Therefore, I cannot provide the requested information based on the provided text. The document is regulatory approval, not a scientific study report.

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.