Search Results
Found 8 results
510(k) Data Aggregation
K Number
K051952Device Name
EUGENONE
Manufacturer
SCIENTIFIC PHARMACEUTICALS, INC.
Date Cleared
2005-09-07
(51 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
SCIENTIFIC PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Eugenone is a eugenol-free temporary cement used in the placement of temporary or temporary placement of permanent prostheses.
Device Description
Eugenone is a eugenol-free temporary cement.
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K Number
K041886Device Name
PROVISO
Manufacturer
SCIENTIFIC PHARMACEUTICALS, INC.
Date Cleared
2004-08-04
(23 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
SCIENTIFIC PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Proviso™ is a self-cured material that is intended for the fabrication of temporary crowns and bridges.
Device Description
Not Found
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K Number
K013555Device Name
SCI-PHARM POST SECURE
Manufacturer
SCIENTIFIC PHARMACEUTICALS, INC.
Date Cleared
2002-01-23
(90 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
SCIENTIFIC PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For cementing dental posts inside prepared postholes, prior to rebuilding the missing coronal tooth structure.
Device Description
Not Found
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K Number
K001446Device Name
LIGHT-CURED ORTHODONTIC BAND CEMENT
Manufacturer
SCIENTIFIC PHARMACEUTICALS, INC.
Date Cleared
2000-07-21
(74 days)
Product Code
DYH
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
SCIENTIFIC PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993324Device Name
CARBOCEM ZINC POLYCARBOXYLATE CEMENT
Manufacturer
SCIENTIFIC PHARMACEUTICALS, INC.
Date Cleared
1999-11-09
(36 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
SCIENTIFIC PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For temporary or permanent cementation of crowns and bridges on non-vital and vital teeth where retention is of primary concern. Also for use as temporary filling material.
Device Description
Carbocem Zinc Polycarboxylate Cement
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K Number
K982915Device Name
SCI-PHARM DFV VARNISH
Manufacturer
SCIENTIFIC PHARMACEUTICALS, INC.
Date Cleared
1999-02-12
(177 days)
Product Code
LBH, IBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
SCIENTIFIC PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use as a varnish on sensitive teeth over exposed dentin and under temporary restoratives and cements.
Device Description
The varnish has the consistency of a viscous liquid. When applied in a thin layer over tooth dentin, the solvent (ethyl alcohol and water) evaporates within a few minutes, leaving a film of Colophony resin in which Sodium Fluoride is suspended, which adheres well to the tooth structure.
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K Number
K983305Device Name
SCI-PHARM DESENSITIZING VARNISH
Manufacturer
SCIENTIFIC PHARMACEUTICALS, INC.
Date Cleared
1998-12-17
(87 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
SCIENTIFIC PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Seals dentin tubulae in order to reduce post-operative sensitivity; will also improve the quality and functionality of restorations when used in conjunction with dental restoratives and cernents.
Device Description
Not Found
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K Number
K982913Device Name
ZINFOS ZINC PHOSPHATE CEMENT
Manufacturer
SCIENTIFIC PHARMACEUTICALS, INC.
Date Cleared
1998-10-19
(61 days)
Product Code
EMA, DAT
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
SCIENTIFIC PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For permanent cementation of Crowns and bridges on non-vital teeth and on vital teeth where the use of Conventional Zinc Phosphate Cements is judged appropriate.
Device Description
ZinFos Zinc Phosphate Cement
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