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510(k) Data Aggregation
K Number
K170529Device Name
Delight, Delight ortho, B&Lite S
Manufacturer
DENTALL Co., Ltd.
Date Cleared
2017-08-08
(167 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
DENTALL Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For light curing polymerization of dental composites, luting materials, cements and other light cured materials.
Device Description
Delight, Delight ortho and B&Lite S are light-emitting diode (LED) type dental curing light that is used for polymerization of light cure resin based composites. They can be used on several different dental materials that are curable by light. The devices use LED that produce a narrow spectrum of blue light in the 430~490nm range, which is useful energy range for activating the CPQ molecule, most commonly used to initiate the photo polymerization of dental monomers. The devices are designed by considering lightweight and portability. They operate on a rechargeable battery, making it easier to carry and use.
The device is not provided sterile and is not intended to be sterilized when used. To prevent cross contamination, users must cover the device with FDA cleared barrier sheath (K132953/ TIDIShield™ Curing Light Sheath). It should be changed between each patient.
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