LogoFDA 510(k) Search
K Number
K091020
Device Name
BLUEPHASE 20I
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2009-06-12

(64 days)

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

For the polymerization of light-curing dental materials curing in the wavelength range of 380-515 nm.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for the bluephase® 20i, an ultraviolet activator for polymerization, and does not contain the detailed information required to fill out the table and answer the questions about acceptance criteria and a study proving device performance.

The FDA letter confirms that the device is substantially equivalent to a legally marketed predicate device, but it does not provide:

  • A table of acceptance criteria and reported device performance.
  • Details about sample sizes for test or training sets.
  • Information on data provenance.
  • The number or qualifications of experts for ground truth.
  • Adjudication methods.
  • Whether MRMC or standalone studies were performed, or their results.
  • The type of ground truth used.
  • How ground truth for training data was established.

This kind of detailed performance data and study methodology is typically found in the 510(k) submission itself or in a separate clinical or performance study report, which is not part of this FDA clearance letter.

§ 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.