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510(k) Data Aggregation
K Number
K093019Device Name
ENAMELITE ACRYSEAL SPRAY SEALANT
Manufacturer
ENAMELITE LLC
Date Cleared
2009-12-22
(84 days)
Product Code
EBD, EBI
Regulation Number
872.3310Why did this record match?
Applicant Name (Manufacturer) :
ENAMELITE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Enamelite Acryseal and Enamelite Acryseal-CB Spray Sealant is intended for use as a sealant/bonding agent intended to reline, repair, or rebase denture surfaces and CAD/CAM produced/milled acrylic and composite replacement dental restorations.
Device Description
Enamelite Acryseal Spray Sealant is a dental sealant or bonding agent which is packaged for aerosol dispensing. The product is formulated as either an acrylic spray sealer or composite spray sealer. The base product is identical to brush on sealants that have been used for over 40 years in the dental profession. The spray on sealant and bonding agent produces the same finished material surface as commonly used brush-on sealants. Enamelite Acryseal Spray sealing and bonding agent produces a much smoother coating compared to a brush-on method and was designed to replace the outdated brush application of sealing/bonding lacquer.
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K Number
K030859Device Name
NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN
Manufacturer
ENAMELITE LLC
Date Cleared
2003-03-27
(9 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
ENAMELITE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Enamelite Porcelain Powders are aerosol devices intended to be used as spray applications of ceramic porcelains and glazes for dental restorations (crowns and bridges), which are produced in dental laboratories.
Device Description
Ceramic Finishing Glaze (Nova Ceramic Spray Glaze). The Enamelite Nova Ceramic Spray Glaze is essentially identical to that used in the Leach and Dillon Shake n Spray powders. It is made of glass frit and is applied to dental restorations in an aerosolized uncontaminated form. Like all other porcelain powders, the Nova Ceramic Spray Glaze is only applied on dental restorations in dental laboratories. As with the parent Leach and Dillon device, the Nova Ceramic Spray Glaze in an aerosol form decreases the in-process time of hand applied glazing methods while providing a substantially more even coating of glaze. Both the parent and modified devices allow the dental technician to apply glaze on either single or multiple units at one time. The Nova Ceramic Spray Glaze is used to construct restorations that fire at temperatures from 650° C to 930° C. Various types of porcelains that are compatible with Nova Glaze include porcelain-fused-to metal, pressed ceramic restorations and milled zircon restorations. The Nova Glaze enables the dental technician the ability to spray a glaze over unfired dental ceramic stains and over unfired add-on porcelains which some restorations may require to esthetically match the dental patient's natural teeth. This flexibility will make these adjustments more efficient for the technician saving multiple firings staining, shading and repairing restorations.
Opaque Porcelain (Tru-Paque) The Tru-Paque opaque porcelain powder is a ceramic opaque spray porcelain intended to mask metal sub-structures. This provides a base layer for bonding additional translucent body porcelain layers of "Porcelain-Fused-to-Metal" (PFM) dental restorations. The purpose of opaque porcelains is to mask the dark color of metal sub-structures called "copings" used in porcelain-fused-to-metal constructed dental restorations, and to provide a layer to which translucent body porcelains are bonded. The Enamelite Tru-Paque is offered in an uncontaminated aerosolized form. As with the parent Leach and Dillon devices, the Tru-Paque opaque porcelain is applied on dental restorations in dental laboratories.
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