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510(k) Data Aggregation
K Number
K972935Device Name
SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL
Manufacturer
Date Cleared
1998-01-29
(174 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
S.S. WHITE MFG., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This material is intended for use in dentistry as a base or cavity liner under permanent restorations and for temporary restorations to teeth as an interim measure to protect cavities before a permanent restoration can be completed.
Device Description
These materials consist of a powder and liquid which, when mixed together, form a setting mass suitable for their intended use.
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K Number
K965083Device Name
SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET
Manufacturer
Date Cleared
1997-04-04
(106 days)
Product Code
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
S.S. WHITE MFG., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
These materials are intended for use in taking impressions of oral tissues for preparation of orthodontic prostheses and to create study models required in designing and fitting of such devices.
Device Description
These materials consist of powders which, when mixed with water, form a setting gel suitable for taking impressions of oral tissues.
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K Number
K964179Device Name
SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS
Manufacturer
Date Cleared
1997-01-09
(83 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
S.S. WHITE MFG., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
These materials are intended for use in preparation of tooth material prior to restoration by etching of the surface.
Device Description
These materials consist of a gel containing ortho-phosphoric acid.
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