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510(k) Data Aggregation
K Number
K023831Device Name
UCP DENTAL MATERIAL
Manufacturer
Date Cleared
2003-01-24
(67 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
PRECIOUS CHEMICALS U.S.A., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The UCP™ Dental Material is used as a bonding agent to facilitate a bond between an opaque porcelain and a gold based metal understructure in the preparation of a Porcelain-Fused-to-Metal-Restoration (PFM). The UCP™ Dental Material is particularly intended for bonding porcelain to a precious metal coping marketed under the trade name "Captek" which received Premarket 510(k) authorization from the FDA in 1994 under the FDA number K932243 HF-2-410 ODE/DGRD.
Device Description
UCP™ Dental Material
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K Number
K023790Device Name
UCC DENTAL MATERIAL
Manufacturer
Date Cleared
2003-01-21
(69 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
PRECIOUS CHEMICALS U.S.A., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The UCC™ Dental Material is used as a bonding agent to facilitate a bond between an opaque resinous veneering material and a gold based metal understructure in the preparation of a Resin-Fused-to-Metal-Restoration (RFM). The UCC™ Dental Material is particularly intended for bonding veneering material to a precious metal coping marketed under the trade name "Captek" which received Premarket 510(K) authorization from the FDA in 1994 under the FDA number K932243 HF-2-410 ODE/DGRD.
Device Description
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