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510(k) Data Aggregation
K Number
K102973Device Name
SILVER DENTAL ARREST
Manufacturer
Date Cleared
2014-07-31
(1394 days)
Product Code
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
**COOLEY **CONSULTING, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Treatment of Dental Hypersensitivity. For use in adults over the age of 21.
Device Description
Not Found
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K Number
K031494Device Name
DOC'S BEST WHITE COPPER CEMENT
Manufacturer
Date Cleared
2003-11-12
(183 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
**COOLEY **& COOLEY, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Doc's Best White Copper Cement is intended for use in luting of all types of restorations (e.g., ceramic, composition, metal) inclusive of bridges and crowns, inlays and onlays, attachments, pins and posts, orthodontic appliances, and cavity liners and primary teeth cavity fillings.
Device Description
The Doc's Best White Copper Cement is a powder that is mixed with an approved aqueous liquid to form a self-curing adhesive cement. The cement is used in the luting of restoration of bridges and crowns, orthodontic appliances as well as cavity liners and primary teeth cavity fillings. The product is provided as a two-part product requiring mixing prior to use.
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