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K Number
K022265
Device Name
LIGHT TIP
Manufacturer
SVENSKA DENTAL INSTRUMENTS AB
Date Cleared
2002-10-02

(82 days)

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

The Light Tip is intended to concentrate the energy and guide the beam to the bottom of the preparation when curing composite materials. The deep composite will therefore be cured first which strengthens the filling, creates contact points and reduces the contraction gap.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental device called "Light Tip." It discusses regulatory aspects, such as substantial equivalence to a predicate device, and general controls, but it does not include any performance study data, acceptance criteria, sample sizes, expert qualifications, or ground truth information. It only provides the indications for use of the device.

§ 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.