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K Number
K984247
Device Name
ELIPAR TRILIGHT
Manufacturer
ESPE DENTAL AG
Date Cleared
1999-02-25

(90 days)

Product Code
EBZ
Regulation Number
872.6070
Type
Traditional
Panel
DE
Reference & Predicate Devices
K803209
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Activator for light-induced intraoral polymerization of resinous dental pit and fissure sealants, restorative materials, bondings, or luting materials

Device Description

ELIPAR® TRILIGHT is classified as an Ultraviolet Activator for Polymerization (21 C.F.R. § 872.6070) because it is a device intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod. (Light-Curing Unit).

ELIPAR® TRILIGHT has the same intended use and is substantially equivalent to ESPE's already 510(k) cleared light-curing unit ELIPAR® (VISIO®). Actually, the ELIPAR® TRILIGHT light source is a further development of the ELIPAR® (VISIO®) light source to provide the patient and user with more comfortable handling and more favorable properties. The Euror® (Visio®) light source is well established and determined to be safe and effective.

AI/ML Overview

This document describes a 510(k) premarket notification for the ELIPAR® TRILIGHT, a light-curing unit for dental polymerization. It states the device's intended use and claims substantial equivalence to a predicate device, ELIPAR® (VISIO®). However, the provided text does not contain any information regarding acceptance criteria, device performance metrics, study designs (sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods), or any comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them because this information is not present in the provided document.

The document primarily focuses on:

  • Contact information of the submitter.
  • Device name, classification, and common name.
  • Predicate device.
  • A general description of the device and its intended use, emphasizing its substantial equivalence to the predicate.
  • The FDA's letter of clearance, confirming substantial equivalence and outlining regulatory responsibilities.
  • Statement of indications for use.

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.