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510(k) Data Aggregation
K Number
K063659Device Name
EASY CURING PEN-STYLE LED CURING LIGHT
Manufacturer
DENT CORP. RESEARCH & DEVELOPMENT
Date Cleared
2007-04-30
(143 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
**DENT CORP. RESEARCH **& DEVELOPMENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Easy-Curing™ is a high intensity blue LED light source, used to polymerize standard, restorative materials, adhesives, and sealants which cure at a wavelength of 450 - 490 nm, off the shelf, dental curing materials in the dentist's clinic.
Device Description
The Easy-Curing™ is a high intensity blue LED light source.
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K Number
K020206Device Name
INTRAORAL CAMERA ME-15
Manufacturer
DENT CORP. RESEARCH & DEVELOPMENT
Date Cleared
2002-04-11
(79 days)
Product Code
EIA
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
**DENT CORP. RESEARCH **& DEVELOPMENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ME-15 Intraoral Camera use only for photographing from a full mouth to a signal tooth. The ME-15 is not intended for any other use.
Device Description
Intraoral Camera ME-15
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K Number
K992233Device Name
APEX LOCATOR BINGO-1020
Manufacturer
DENT CORP. RESEARCH & DEVELOPMENT
Date Cleared
1999-11-30
(158 days)
Product Code
LQY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
**DENT CORP. RESEARCH **& DEVELOPMENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BINGO-1020 is a modern device for precise apex localization during root channel treatment.
Device Description
BINGO-1020 is distinguished by increasing precision at 0.1mm on wet/dry, large graphic display where current position of endo file is reflected and other essential information is displayed.
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