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Found 14 results
510(k) Data Aggregation
(189 days)
VIDENT
The Titanium Scalloped abutments are designed for use with Nobel Biocare® Brånemark™ external hex, 31™ external hex and Zimmer® internal hex dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis cemented onto the abutment. The abutments are indicated for full arch or partially endentulous patient restoration including single implant restorations,
Titanium Scalloped Abutment
This document is a 510(k) premarket notification letter from the FDA to VIDENT regarding their Titanium Scalloped Abutment. It confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market. However, this letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The document is a regulatory approval notice, not a study report. Therefore, I cannot extract the requested information from this text.
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(65 days)
VIDENT
Vita VM® porcelains are indicated for use as a veneering material for fixed prosthesis in crowns, bridges, and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to a ceramic or metal substructure into the shape of a dental crown.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental device called "Vita VM® Porcelain Powder for Clinical Use." It grants clearance based on substantial equivalence to a predicate device.
Crucially, this document does NOT contain information about acceptance criteria, a specific study proving the device meets those criteria, or any details related to sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The letter is a regulatory approval document and focuses on:
- Device Identification: Trade Name, Regulation Number, Regulation Name, Product Code.
- Regulatory Classification: Class II.
- Substantial Equivalence: The FDA has determined the device is substantially equivalent to a legally marketed predicate device.
- Conditions of Marketing: Subject to general controls (registration, listing, GMP, labeling) and potentially additional controls for Class II devices.
- Indications for Use: Vita VM® porcelains are indicated as a veneering material for fixed prostheses (crowns, bridges, dental implant abutments)
- User: By or on the order of a dental professional (DDS or DMD).
Therefore, I cannot provide the requested information based solely on the provided text. The information requested typically comes from a detailed "510(k) Summary" or the full "510(k) Premarket Notification" submission itself, which would include performance data and testing details. This letter is the FDA's response to that submission, not the submission itself.
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(106 days)
VIDENT
Vita VM® porcelains are indicated for use as a veneering material for fixed prosthesis in crowns, bridges, and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to a ceramic or metal substructure into the shape of a dental crown.
For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.
Vita VM® porcelains are indicated for use as a veneering material for fixed prosthesis in crowns, bridges, and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to a ceramic or metal substructure into the shape of a dental crown.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental product called "Vita VM®" (porcelain powder for clinical use).
The letter confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It discusses regulatory requirements, classifications, and contact information, but it does not detail any specific performance acceptance criteria or a study conducted to demonstrate the device meets such criteria.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details.
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(10 days)
VIDENT
In-Ceram® 2000 AL CUBES for inLab® are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; for single unit anterior or posterior crowns and 3 unit anterior bridges.
Substructures of AL Cubes for Cerec are machined using the Cerec 2, Cerec 3 and InLab cad/cam systems.
For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.
Vita In-Ceram® 2000 AL Cubes for inLab® are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; for single unit anterior or posterior crowns and 3 unit anterior bridges. Substructures of AL Cubes for Cerec are machined using the Cerec 2, Cerec 3 and InLab cad/cam systems.
The provided document is a 510(k) premarket notification letter from the FDA regarding "Vita In-Ceram® 2000 AL Cubes for inLab®". It states that the device is substantially equivalent to legally marketed predicate devices and outlines general control provisions and other regulations.
However, the document does not contain specific information about acceptance criteria, device performance metrics, sample sizes, expert qualifications, adjudication methods, or study designs (e.g., MRMC, standalone) as requested in your prompt. This type of information is typically found in the test reports, clinical study summaries, or performance sections of a 510(k) submission, but it is not detailed in the FDA's decision letter provided here.
Therefore, I cannot provide the requested table and information based on the given text. The document confirms the device's classification and allows it to be marketed, but it does not delve into the technical validation studies that led to that determination.
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(29 days)
VIDENT
Vita PM7 pressable ceramic is to be used for the fabrication of
- Single and multi-surface inlays O
- Onlays o
- Veneers O
- Partial crowns ্
- Anterior crowns 0
- Premolar crowns o
Also for oxide-ceramic crown and bridge substructures to be veneered with conventional porcelain.
For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product named "Vita PM7 Pressable Ceramic." It primarily addresses the regulatory approval of the device based on substantial equivalence to a predicate device.
This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific study-related details requested in the prompt.
The letter confirms that the device is classified as Class II and can be marketed subject to general controls. It also includes the "Indications for Use" for the device, which specify the types of dental restorations it can be used for (e.g., inlays, onlays, veneers, crowns).
Therefore, I cannot provide the requested information based on the given input.
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(30 days)
VIDENT
Vita In-Ciram YZ® Cubes for Cerec® is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crowns and bridges. Sub tructures of YZ® Cubes for Cerec® are machined using the Cerec 2, Cerec 3 and InLat; systems.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding a dental device called "Vita In-Ceram YZ® Cubes for Cerec®." This document confirms the device's substantial equivalence to a predicate device and outlines general regulatory requirements.
However, the document does NOT contain any information about acceptance criteria, device performance studies, or the methodologies used to establish ground truth or training sets. Therefore, I cannot extract the requested information.
The 510(k) letter is a regulatory approval document, not a scientific study report. It states that the device is "substantially equivalent" to an existing legally marketed device, which typically means it has similar intended use, technological characteristics, and performs as safely and effectively as the predicate device. The detailed performance data and study methodologies you're asking for would usually be part of the submission package that led to this approval, but they are not included in this letter.
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(405 days)
VIDENT
Ceramic hextop abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis.
The ITI® ceramic coping is intended to be seated on the implant/abutment complex and serve as a base for the prosthetic reconstruction. The prefabricated coping provides a machined inner surface for mating with the abutment and implant, while the outer surface can be adapted to the individual restoration.
Not Found
I am sorry, but based on the provided text, there is no information regarding acceptance criteria related to device performance or a study demonstrating that the device meets such criteria.
The document is an FDA 510(k) clearance letter for two dental devices: "Ceramic Hextop Abutment" and "SynOcta® In-Ceram Coping" (also referred to as "ITI® Dental Implant System - Ceramic Coping"). This type of letter addresses substantial equivalence to existing legally marketed predicate devices, not performance criteria or clinical study results in the manner requested.
The letter explicitly states: "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."
Therefore, I cannot provide the requested information.
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(85 days)
VIDENT
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(75 days)
VIDENT
PDQ and PDQ-Ti abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis.
PDQ and PDQ-Ti Abutments
This is a 510(k) clearance letter from the FDA for dental abutments. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices.
Therefore, I cannot extract the requested information from the provided text. The document is an administrative clearance, not a technical report detailing performance studies.
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(86 days)
VIDENT
Wide Body abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments which do not osseointegrate are to be seated directly on tope of the implant body. The abutments form the substructure of the restored prosthesis.
Wide Body Abutments
The provided document is a 510(k) clearance letter from the FDA for "Wide Body Abutments". This document does not contain information about acceptance criteria, device performance testing, or study details as typically found in a clinical study report or a 510(k) submission summary for an AI/ML medical device.
The information requested in the prompt (acceptance criteria, sample size, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is specific to the evaluation of AI/ML software or diagnostic devices. The device described in this document is a physical dental implant component (Wide Body Abutments), which would be evaluated based on mechanical properties, biocompatibility, and fit, rather than AI performance metrics.
Therefore, I cannot provide the requested information based on the given document.
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