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510(k) Data Aggregation
K Number
K113575Device Name
HILLA DIGITAL TRANSFERS
Manufacturer
Date Cleared
2012-03-07
(96 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
HILLA TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HILLA DIGITAL TRANSFERS are colored ceramic stains, supplied in a decal form, for firing onto dental ceramic prosthetic devices.
Device Description
HILLA DIGITAL TRANSFERS are ceramic stain powders in a decal form, for application to dental ceramic prosthetic devices. The decals are applied and fired on ceramic dental restorations. After firing the decal, what remains is a silicate ceramic stains, which are substantially equivalent to the silicate ceramic stains disclosed in K000983.
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