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510(k) Data Aggregation
K Number
K063626Device Name
DURAFLEX
Manufacturer
COSMETIC DENTAL MATERIALS INC
Date Cleared
2007-02-08
(64 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
COSMETIC DENTAL MATERIALS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DuraFlex thermoplastic resin is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
Device Description
The DuraFlex material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.
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K Number
K052040Device Name
QUICKSMILE
Manufacturer
COSMETIC DENTAL MATERIALS INC
Date Cleared
2005-10-18
(82 days)
Product Code
EEG
Regulation Number
872.6475Why did this record match?
Applicant Name (Manufacturer) :
COSMETIC DENTAL MATERIALS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QuickSmile light is intended to emit light in the 600-700 nanometer spectrum to provide a heat source for bleaching teeth.
Device Description
The QuickSmile light is intended for use by a dental professional as a tooth whitening system. The whitening light heat source is a stand alone unit which emits a biologically safe and effective level of red visible light, which can penetrate the tooth and activate the photoactive substances within the tooth yielding a minimal amount of heat. The general wavelength is 600-700 nanometers. The LED light emits approximately 1º-3º C heat against the tooth surface. To ensure user safety when operating the light, the light has built in features to eliminate any risk for the end user and dental professional. First, the light automatically shuts off after a specified period of time designated by the dental professional. Secondly, the light is supplied with specially designed safety glasses for the patient and dental professional that stop the penetration of the red/orange wavelength and protect the vision of the patient and dental professional.
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