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510(k) Data Aggregation
K Number
K984037Device Name
CORE-IDE
Manufacturer
ROYDENT DENTAL PRODUCTS, INC.
Date Cleared
1999-02-04
(84 days)
Product Code
EBD
Regulation Number
872.3310Why did this record match?
Applicant Name (Manufacturer) :
ROYDENT DENTAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DC-Core / Core-Ide is a self cure micro hybride composite for endodontic post cementations and core build-ups (see enclosed Instruction for Use, MSDS).
Device Description
The chemistry of DC-Core / Core-Ide P. L. Superior GmbH distributes for Roydent is commonly used in current dental materials. The purpose of this material for use by the dentist is to clinically build up human teeth (restauration in the case of mostly destroyed tooth structure). The material is in general placed against an applied adhesive system.
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K Number
K983357Device Name
MUCOPREN SOFT RELINING SYSTEM
Manufacturer
ROYDENT DENTAL PRODUCTS, INC.
Date Cleared
1998-11-13
(50 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
ROYDENT DENTAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use as a long-term resilient lining material for removable dentures, to reline, repair, or rebase dentures.
Device Description
Not Found
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K Number
K954281Device Name
PANASIL IMPRESSION MATERIAL
Manufacturer
ROYDENT DENTAL PRODUCTS, INC.
Date Cleared
1996-06-24
(285 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
ROYDENT DENTAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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