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Found 7 results
510(k) Data Aggregation
K Number
K001719Device Name
Q-LUX PLASMA 100 LIGHT CURE UNIT
Manufacturer
ROLENCE ENTERPRISE CO. LTD.
Date Cleared
2000-10-10
(127 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
ROLENCE ENTERPRISE CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991865Device Name
Q-LITE 75 LIGHT CURE UNIT
Manufacturer
ROLENCE ENTERPRISE CO. LTD.
Date Cleared
1999-07-20
(49 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
ROLENCE ENTERPRISE CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TO PRODUCE LIGHT RANGE BETWEEN 400 & SOCIE CURE COMPOSITES CURED DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES, PIT AND FISSURE SEALANTS, BONDING AGENTS, ADESION AND ARRESPANCE PIT AND FISSORE OFADINATE, ESTIGRATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT.
Device Description
Not Found
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K Number
K991863Device Name
CUTE-LITE I LIGHT CURE UNIT
Manufacturer
ROLENCE ENTERPRISE CO. LTD.
Date Cleared
1999-07-19
(48 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
ROLENCE ENTERPRISE CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TO PRODUCE LIGHT RANGE BETWEEN 400 & 500 NM TO POLYMERIZE LIGHT CURED DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES, PIT AND FISSURE SEALANTS, BONDING AGENTS, ADHESION PRIMERS ETC. WHICH ARE APPLIED IN THE RESTORATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT.
Device Description
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K Number
K980792Device Name
CU-100A LIGHT CURE UNIT
Manufacturer
ROLENCE ENTERPRISE CO. LTD.
Date Cleared
1998-05-15
(74 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
ROLENCE ENTERPRISE CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TO PRODUCE LIGHT FOR FORME MATERIAL SUCH AS LIGHT CURE COMPOSITES, CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES , CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMESSITES , CURE DENTAL SESTORATIVE BONDING AGENTS, ADENTS, ADHESTON PRIMERS ETC. PIT AND FISSURE SEALANTS, BONDING AGENTS, FECTION AND APPEARANCE WHICH ARE APPLIED IN THE RESTORATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT.
Device Description
Not Found
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K Number
K980793Device Name
Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT
Manufacturer
ROLENCE ENTERPRISE CO. LTD.
Date Cleared
1998-05-15
(74 days)
Product Code
EBF, EBE
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
ROLENCE ENTERPRISE CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TO PRODUCE LIGHT RANGE BETWEEN 400 & 500 NM TO POLYMERIZE LIGHT CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES, PIT AND FISSURE SEALANTS, BONDING AGENTS, ADHESION PRIMERS ETC. WHICH ARE APPLIED IN THE RESTORATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT.
Device Description
Not Found
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K Number
K960351Device Name
Q-LUX LIGHT CURE UNIT
Manufacturer
ROLENCE ENTERPRISE CO. LTD.
Date Cleared
1996-04-15
(81 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
ROLENCE ENTERPRISE CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K960364Device Name
CU-200 LIGHT CURE UNIT
Manufacturer
ROLENCE ENTERPRISE CO. LTD.
Date Cleared
1996-04-15
(81 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
ROLENCE ENTERPRISE CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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