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510(k) Data Aggregation
(88 days)
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
Not Found
The provided documentdoes not contain information about acceptance criteria or a study proving device performance against such criteria.
The document is a 510(k) premarket notification letter from the FDA to DMP. Limited regarding their "Bright Restorative Materials". It states that the device has been determined to be substantially equivalent to legally marketed predicate devices.
The content primarily focuses on:
- The FDA's determination of substantial equivalence.
- Regulatory information and obligations for the manufacturer.
- Indications for use for various Bright Restorative Materials.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, ground truth details, or information about MRMC studies.
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(106 days)
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
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
I'm sorry, but without further context, it is not possible to describe the acceptance criteria and the study that proves the device meets those criteria from the provided document. The document is an FDA 510(k) clearance letter for dental impression materials. It details the device name, intended use, and indications for use, but does not provide information about specific acceptance criteria or studies conducted to prove the device meets them.
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(115 days)
- Pits and fissures of molars and premolars
- Fissures on the lingual sides of anterior teeth
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) clearance letter for a dental pit and fissure sealant, which confirms that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements but does not include details on performance studies, acceptance criteria, or ground truth establishment.
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(105 days)
- · Bonding agent (bonding liquid) for adhesive restorations
- · Transparent sealant for fissures and restorations
- Bonding layer for the repair of resin-, crown-, or bridge works .
Not Found
This document is a letter from the FDA regarding a 510(k) premarket notification for a dental bonding agent, DMP Single Bonding. It does not contain information about the acceptance criteria or a study that proves the device meets specific performance metrics. Therefore, I cannot extract the requested information.
The letter focuses on the substantial equivalence determination for the device, stating that it can be marketed subject to general controls and regulations. It does not provide any technical performance data, study designs, or ground truth establishment details.
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(105 days)
- · Etching the enamel and dentin for adhesive restorations ·
Not Found
I am sorry, but based on the provided document, I cannot answer the request. The document is a 510(k) premarket notification letter for a dental etching gel (DMP Etching Gel). It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, details about AI assistance studies, standalone algorithm performance, or how ground truth was established. It focuses solely on the regulatory clearance process for a dental product.
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(101 days)
- 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
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a dental restorative material called NANOCERAM-BRIGHT. This document is related to regulatory clearance and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information based on the input text. The document confirms the device's regulatory classification and lists its intended uses but does not include any technical study details.
Ask a specific question about this device
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