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510(k) Data Aggregation
K Number
K250009Device Name
LED Curing Light (C01-X, C02-X)
Manufacturer
Premium Plus (Dongguan) Limited
Date Cleared
2025-04-10
(98 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
Premium Plus (Dongguan) Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LED Curing Light is intended for use by trained dental professionals only for the purpose of light curing dental resins and composites.
Device Description
LED Curing Light is classified as an Ultraviolet Activator for Polymerization (21 CFR 872.6070). It is used for polymerization of dental light cured materials by dental professionals. The device is based on blue LED (light emitting diode) technology. It has four curing modes. Using different modes gives dental professionals the flexibility to polymerize virtually dental resins and composites.
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K Number
K220662Device Name
Disposable Barrier Sleeves
Manufacturer
Premium Plus (Dongguan) Limited
Date Cleared
2022-05-11
(65 days)
Product Code
PEM
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
Premium Plus (Dongguan) Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Barrier Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
Device Description
Not Found
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