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K Number
K021797
Device Name
L.E.DEMETRON
Manufacturer
SYBRON DENTAL SPECIALTIES, INC.
Date Cleared
2002-06-27

(27 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

The L.E.Demetron is a cordless LED curing light intended for polymerization of visible light cured materials.

Device Description

The L.E.Demetron Cordless Curing Light is a device used for the polymerization of dental materials using visible light. It consists of a cordless LED curing handpiece, a battery charger with built-in radiometer, and a remote handpiece holder. The plastic molded handpiece will contain a detachable rechargeable battery pack, an LED light "engine", and a cooling fan. A printed circuit board with a digital circuit will be utilized to control three (3) different curing modes. Each mode specifies LED timing, fan timing and audible beep timing. A segmented display will depict the curing mode and LED timing. A pushbutton switch will be used to scroll between the curing modes. A separate pushbutton "trigger switch" will activate the light. The molded plastic battery charger will have a single well for charging the battery pack, and indictor lights to indicate battery charge status. Indictor lights will also depict light output from the built-in radiometer.

AI/ML Overview

The provided text is a 510(k) summary for the L.E.Demetron Cordless LED Curing Light. It describes the device, its intended use, and claims substantial equivalence to an existing predicate device (3M ESPE AG, Elipar FreeLight).

However, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory submission for premarket notification, focusing on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The text does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for any test set.
  3. Number or qualifications of experts used for ground truth.
  4. Adjudication method.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Results of a standalone algorithm performance study.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The document primarily focuses on:

  • Device identification and classification.
  • Description of the device and its components.
  • Intended use.
  • Claim of substantial equivalence to a predicate device.
  • Formal FDA correspondence regarding the 510(k) clearance.

§ 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.