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510(k) Data Aggregation
K Number
K122974Device Name
TRYOUT-VPS HOLDING PASTE
Manufacturer
Date Cleared
2013-05-17
(233 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
CROWN DELTA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Crown Delta's TRYOUT – Translucent Shade VPS Holding Paste is to be used for the temporary stabilization of ceramic crowns and veneers on prepared teeth while the dentist evaluates fit, re-contours and/or trims, and performs an esthetic assessment prior to permanent fixation with cement.
Device Description
TRYOUT - Translucent Shade VPS Holding Paste
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K Number
K041028Device Name
CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL
Manufacturer
Date Cleared
2004-05-14
(23 days)
Product Code
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
CROWN DELTA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Crown Delta's Hydrophilic vinyl polysiloxane impression material will be used for making impressions of the teeth and gums of patients requiring models for study and/or for production inflorotive of the testic devices. The impression material is intended to be applied via a dual be rooterative prosem either into an impression tray or directly onto the patient's teeth. The "hydrophilic" enhancement will enable production of more accurate impression when adverse conditions (e.g. the presence of blood or saliva) are present.
Device Description
Crown Delta Hydrophilic Impression Material is a hydrophilic vinyl polysiloxane impression material.
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K Number
K955288Device Name
HEARING AID IMPRESSION MATERIAL
Manufacturer
Date Cleared
1996-02-02
(78 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
CROWN DELTA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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