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Found 14 results
510(k) Data Aggregation
K Number
K141839Device Name
PREMIER ETCH
Manufacturer
PREMIER DENTAL PRODUCTS CO.
Date Cleared
2014-11-17
(132 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
PREMIER DENTAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Premier Etch is a prescription- only, 37% phosphoric acid etchant in a gel form that is used by the dental professional for etching dentin or enamel prior to tooth restoration.
Device Description
Premier Etch is a prescription- only, 37% phosphoric acid etchant in a gel form.
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K Number
K132526Device Name
KNIT-PAK+
Manufacturer
PREMIER DENTAL PRODUCTS CO.
Date Cleared
2013-11-26
(106 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PREMIER DENTAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Knit-Pak+, a prescription-only, Aluminum Chloride Hexahydrate impregnated cord is used for temporary chemo-mcchanical retraction of gingival tissues and hemostasis of the gingival margin around the tooth. It is intended for accurate and enhanced results when acquiring dental impressions, for cavity preparation or wherever hemostasis and retraction is required.
Device Description
Knit-Pak+, a prescription-only, Aluminum Chloride Hexahydrate impregnated cord
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K Number
K131212Device Name
PREMIER CERAMIC PRIMER
Manufacturer
PREMIER DENTAL PRODUCTS CO.
Date Cleared
2013-08-26
(119 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
PREMIER DENTAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Premier Ceramic Primer is a prescription-only, one-step silane coupling agent intended for preparation of ceramic materials such as porcelain, ceramic, hybrid ceramic or composite resin and zirconia restorations designed to improve adhesion to resin materials prior to cementation or restoration. This primer does not require prior sandblasting or the use of an etchant.
Device Description
Not Found
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K Number
K083695Device Name
TRAXODENT
Manufacturer
PREMIER DENTAL PRODUCTS CO.
Date Cleared
2009-04-28
(134 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PREMIER DENTAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K062166Device Name
ENAMEL PRO
Manufacturer
PREMIER DENTAL PRODUCTS CO.
Date Cleared
2006-11-21
(116 days)
Product Code
EJR
Regulation Number
872.6030Why did this record match?
Applicant Name (Manufacturer) :
PREMIER DENTAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
Device Description
Not Found
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K Number
K062683Device Name
ENAMEL PRO VARNISH
Manufacturer
PREMIER DENTAL PRODUCTS CO.
Date Cleared
2006-11-21
(74 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
PREMIER DENTAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Enamel Pro® Varnish is a fluoride containing preparation for the treatment of dentinal hypersensitivity, and for the reduction of post operative sensitivity. The varnish can be placed on sensitive root surfaces and under temporary restoratives and cements in order to seal exposed dentinal tissue. It can be used as a cavity liner.
Device Description
Not Found
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K Number
K061997Device Name
PREMIER SELF-ETCHING ENAMEL SEALANT
Manufacturer
PREMIER DENTAL PRODUCTS CO.
Date Cleared
2006-10-04
(82 days)
Product Code
EBC
Regulation Number
872.3765Why did this record match?
Applicant Name (Manufacturer) :
PREMIER DENTAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Premier Self-Etching Enamel Sealant is for the preventive sealing of pits and fissures in the primary and secondary dentition, utilizing the self-etching technique. Secondarily, the material can be used as a sealant/lining under amalgam restorations.
Device Description
Not Found
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K Number
K061998Device Name
PREMIER SELF-ETCHING BOND ENHANCER
Manufacturer
PREMIER DENTAL PRODUCTS CO.
Date Cleared
2006-10-04
(82 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
PREMIER DENTAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Premier Self-Etching Bond Enhancer is a no-rinse multi-purpose adhesive primer and bond coupling agent designed to work with existing bonding agents. When used with dental bonding agents, Premier Self-Etching Bond Enhancer can be used for bonding composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up material and for bonding veneers, onlays and inlays.
Device Description
Premier Self-Etching Bond Enhancer is a no-rinse multi-purpose adhesive primer and bond coupling agent designed to work with existing bonding agents.
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K Number
K051866Device Name
PREMIER TEMPORARY CEMENT
Manufacturer
PREMIER DENTAL PRODUCTS CO.
Date Cleared
2005-09-06
(57 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
PREMIER DENTAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Premier Temporary Cement is recommended for the cementation of temporary crowns, bridges, inlays and onlays.
Device Description
Not Found
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K Number
K042215Device Name
RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT
Manufacturer
PREMIER DENTAL PRODUCTS CO.
Date Cleared
2004-09-21
(36 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
PREMIER DENTAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cementation of Gutta-Percha in root canal using the single cone technique.
Device Description
Not Found
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