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510(k) Data Aggregation
K Number
K121915Device Name
BRIGHT RESTORATIVE MATERIALS
Manufacturer
Date Cleared
2012-09-28
(88 days)
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DMP LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BRIGHT Restorative Materials, to include:
- NANOCERAM BRIGHT FLOW .
- BRIGHT FLOW CORE .
- BRIGHT HEAVY CORE .
- BRIGHT LIGHT .
- BRIGHT LIGHT FLOW .
- · BRIGHT POSTERIOR
Indications for Use:
NANOCERAM - BRIGHT FLOW
Indications for use:
- · Fillings of minimally invasive cavities of all classes
- Fillings of small class I cavities .
- Fillings of class II-V cavities including V-shaped defects and cervical caries
- Extended fissure sealing
- Cavity lining as the first layer for Class I and II restorations
- Splinting of mobile teeth ●
- Blocking out of undercuts
- Small restorations of all types
- Repair of composite restorations and ceramic veneers
BRIGHT FLOW CORE - BRIGHT HEAVY CORE
Indications for use:
- Core build up of vital and non-vital teeth .
- Post cementation
BRIGHT LIGHT - BRIGHT LIGHT FLOW
BRIGHT LIGHT
Indications for use:
- Class I-V restorations .
- Reconstruction of affected anterior teeth ●
- Veneering of discoloured anterior teeth .
- Splinting of mobile teeth
- Repair of composite and ceramic veneers
BRIGHT LIGHT FLOW
Indications for use:
- · Fillings of minimally invasive cavities of all classes
- Fillings of class II-V cavities including V-shaped defects and cervical caries .
- Extended fissure sealing .
- Splinting of mobile teeth .
- Blocking out of undercuts .
- Small restorations of all types .
- Repair of composite restorations and ceramic veneers
BRIGHT POSTERIOR
Indications for use:
- · Direct posterior restorations (Class I and II), including occlusal surfaces
- Core build ups ●
- Splinting of mobile teeth
Device Description
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K Number
K102836Device Name
BONASIL A+ IMPRESSION MATERIALS
Manufacturer
Date Cleared
2011-01-13
(106 days)
Product Code
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
DMP LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Bonasil A* Impression Materials are intended to:
- be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums;
- provide models for study and for production of restorative prosthetics devices;
Indications for use:
- BONASIL A* Putty (putty normal set, putty fast set, putty extra hard, lab putty) is to be used as a preliminary material for:
- Two step putty/wash technique
- Single step putty/wash technique
- Functional peripheries
- Crown/bridge work
- Inlays, onlays
- BONASIL A* Heavy (heavy normal set, heavy fast set) is to be used as a heavy body material for:
- Two step putty/wash technique
- Single step putty/wash technique
- Functional peripheries
- Crown/bridge work
- Inlays, onlays
- BONASIL A* Monophase (monophase normal set, monophase fast set) is to be used as a semi-heavy body material for:
- Single step putty/wash technique
- Functional peripheries
- Crown/bridge work
- Inlays, onlays
- BONASIL A* Regular (regular normal set, regular fast set) is to be used as a medium body material for:
- Two step putty/wash technique
- Single step putty/wash technique
- Functional peripheries
- Reline impressions
- Crown/bridge work
- Inlays, onlays
- BONASIL A* Light (light normal set, light fast set) is to be used as a light body material for:
- Two step putty/wash technique
- Single step putty/wash technique
- Functional peripheries
- Reline impressions
- Crown/bridge work
- Inlays, onlays
- BONASIL A* Bonabite (bonabite fast set) is to be used as a light body material for:
- Making accurate occlusal registrations
- Standards bite registrations in the end bite position
- Key material for needle point registration
- Production of small model segments
- An optical registration of occlusal data for CAD/CAM/CIM systems
- BONASIL A* Alginate free (normal set, fast set) is an alternative to traditional alginate materials and is suitable for:
- Preliminary impressions
- Anatomic models
- Fabricating temporary crowns and bridges
- Opposing dentition
- Fabricating simple removable prosthetic restorations
- Orthodontic work
- Case study models
Device Description
The Bonasil A* Impression Materials are intended to:
- be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums;
- provide models for study and for production of restorative prosthetics devices;
Indications for use:
- BONASIL A* Putty (putty normal set, putty fast set, putty extra hard, lab putty) is to be used as a preliminary material for:
- Two step putty/wash technique
- Single step putty/wash technique
- Functional peripheries
- Crown/bridge work
- Inlays, onlays
- BONASIL A* Heavy (heavy normal set, heavy fast set) is to be used as a heavy body material for:
- Two step putty/wash technique
- Single step putty/wash technique
- Functional peripheries
- Crown/bridge work
- Inlays, onlays
- BONASIL A* Monophase (monophase normal set, monophase fast set) is to be used as a semi-heavy body material for:
- Single step putty/wash technique
- Functional peripheries
- Crown/bridge work
- Inlays, onlays
- BONASIL A* Regular (regular normal set, regular fast set) is to be used as a medium body material for:
- Two step putty/wash technique
- Single step putty/wash technique
- Functional peripheries
- Reline impressions
- Crown/bridge work
- Inlays, onlays
- BONASIL A* Light (light normal set, light fast set) is to be used as a light body material for:
- Two step putty/wash technique
- Single step putty/wash technique
- Functional peripheries
- Reline impressions
- Crown/bridge work
- Inlays, onlays
- BONASIL A* Bonabite (bonabite fast set) is to be used as a light body material for:
- Making accurate occlusal registrations
- Standards bite registrations in the end bite position
- Key material for needle point registration
- Production of small model segments
- An optical registration of occlusal data for CAD/CAM/CIM systems
- BONASIL A* Alginate free (normal set, fast set) is an alternative to traditional alginate materials and is suitable for:
- Preliminary impressions
- Anatomic models
- Fabricating temporary crowns and bridges
- Opposing dentition
- Fabricating simple removable prosthetic restorations
- Orthodontic work
- Case study models
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K Number
K102252Device Name
DMP PIT & FISSURE SEALANT
Manufacturer
Date Cleared
2010-12-03
(115 days)
Product Code
Regulation Number
872.3765Why did this record match?
Applicant Name (Manufacturer) :
DMP LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- Pits and fissures of molars and premolars
- Fissures on the lingual sides of anterior teeth
Device Description
Not Found
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K Number
K102254Device Name
DMP SINGLE BONDING
Manufacturer
Date Cleared
2010-11-23
(105 days)
Product Code
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
DMP LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- · Bonding agent (bonding liquid) for adhesive restorations
- · Transparent sealant for fissures and restorations
- Bonding layer for the repair of resin-, crown-, or bridge works .
Device Description
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K Number
K102255Device Name
DMP ETCHING GEL
Manufacturer
Date Cleared
2010-11-23
(105 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DMP LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Etching the enamel and dentin for adhesive restorations
Device Description
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K Number
K102257Device Name
NANOCERAM- BRIGHT
Manufacturer
Date Cleared
2010-11-19
(101 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DMP LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- Anterior restorations (Class III, IV)
- Posterior restorations (Class I, II)
- Class V restorations (Cervical caries, root erosion, wedge shaped defects)
- Veneering of discolored anterior teeth
- Splinting of mobile teeth . : .
- Repair of composite and ceramic veneers
Device Description
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