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Found 4 results
510(k) Data Aggregation
(111 days)
Grandio Flow is intended for the following applications:
- filling minimally invasive cavities of all classes -
- filling small class I cavities and extended fissure sealing -
- filling class II-V cavities including V-shaped defects and cervical caries -
- blocking out undercuts -
- lining or coating cavities -
- repairing fillings and veneers -
- luting translucent prosthetic pieces (e.g. full ceramic crowns, etc.) -
Not Found
The provided document is an FDA 510(k) clearance letter for a dental resin material (Grandio Flow). It is not a study report or clinical trial documentation for an AI/CADe/CADx device. Therefore, it does not contain any of the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement for such studies.
The document indicates that the device Grandio Flow is a "Tooth Shade Resin Material" and is classified as "Regulatory Class: II" with product code "EBF". The 510(k) clearance states that the device is "substantially equivalent" to legally marketed predicate devices. This type of clearance for this product category does not typically involve the kind of performance studies with acceptance criteria, ground truth, and expert review that would be conducted for a diagnostic AI device.
Therefore, I cannot extract the requested information from this document.
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(83 days)
Grandio Flow Try-In assists the dentist in selecting the correct shade for cementing with Grandio Flow Try-In assists the dentist in oblocing the other watch the shades of polymerized Grandio Flow composites.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental material (Grandio Flow Try-In). It does not contain information about acceptance criteria or a study proving a device meets such criteria for an AI/ML powered device. The letter is for a physical dental product and not a software device that would typically have the kind of performance metrics you are asking about.
Therefore, I cannot provide the requested information based on the given document.
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(16 days)
- Fillings of any minimally invasive cavity
- Fillings of small cavities and extended fissure sealing
- Block out undercuts
- Lining or coating cavities
- Elling of couling vincluding V-shaped defects and cervical caries
- Repair of fillings and veneers
- Repair of filling of translucent prosthetic pieces, e.g., porcelain-only crowns
Not Found
This is a 510(k) premarket notification for a dental resin material, not an AI/ML powered device. As such, the information requested regarding acceptance criteria and studies proving device performance with respect to AI/ML specific metrics (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.
The document discusses the substantial equivalence of the Grandio Flow dental resin to legally marketed predicate devices. The review process for such a device focuses on material properties, biocompatibility, and intended use, rather than AI/ML algorithm performance.
Therefore, I cannot provide the requested table and study details as they pertain to AI/ML devices.
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(56 days)
- Fillings of any minimally invasive cavity
- Fillings of small cavities and extended fissure sealing
- Block out undercuts
- Lining or coating cavities
- Class III-V fillings, including V-shaped defects and cervical caries
- Repair of fillings and veneers
- Luting of translucent prosthetic pieces, e.g., porcelain-only crowns
Not Found
I am sorry, but based on the provided text, I cannot provide a detailed answer to your request. The document is an FDA 510(k) clearance letter for a dental resin material named "Grandio® Flow." While it lists the indications for use of the device, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details related to AI or comparative effectiveness studies.
The document is a regulatory approval notice, not a technical report on device performance or a study description.
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