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510(k) Data Aggregation
K Number
K091096Device Name
NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100
Manufacturer
DENTAL SOLUTIONS, INC.
Date Cleared
2009-06-18
(63 days)
Product Code
EIH, ETH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
DENTAL SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NaturaZ Series is used in the manufacture of dental prosthetics. The Dental Solution, Inc. proposes that the materials distributed within the United States be labeled: 'CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals."
Device Description
NaturaZ Series is a pre-formed material for use by dental laboratories. NaturaZ Series is used in the manufacture of dental prosthetics.
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