(267 days)
Creation
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No
The device description is for a dental porcelain, and there is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as a material for dental restorations (crowns or bridges) rather than a device designed to treat a medical condition or disease.
No
The device is a dental material used for restorations (crowns or bridges), not for diagnosing medical conditions.
No
The device description clearly states it is a "feldspathic porcelain supplied for fusing to a metal sub-structure," indicating it is a physical material used in dental restorations, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The description clearly states the device is a "feldspathic porcelain supplied for fusing to a metal sub-structure to form an aesthetic restoration which is then fitted as a crown or bridge." This describes a material used for dental restorations, which are implanted or fitted onto the body, not used for testing samples taken from the body.
- Lack of IVD Indicators: The document lacks any information typically associated with IVDs, such as:
- Intended Use/Indications for Use related to testing or diagnosis.
- Mentions of samples (blood, urine, tissue, etc.).
- Performance metrics like sensitivity, specificity, AUC, etc., which are crucial for evaluating diagnostic tests.
Therefore, this device falls under the category of a dental material used for restorative purposes, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The device is a feldspathic porcelain supplied for fusing to a metal sub-structure to form an aesthetic restoration which is then fitted as a crown or bridge.
Product codes
Not Found
Device Description
The device is a feldspathic porcelain supplied for fusing to a metal sub-structure to form an aesthetic restoration which is then fitted as a crown or bridge. Both products are supplied with different layers ie; opaque, dentine, enamel etc. in order to replicate different colour layers in a natural tooth. Both products are supplied as a powder for mixing together with a liquid to form a paste or as a pre-mixed paste.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Both products have essentially the same firing characteristics including low temperature for insertion into the furnace, drying time, final temperature and requirement for vacuum. Both products are manufactured to conform to ISO 9693:1991 Dental Ceramic Fused to Metal Restorative Material. This standard specifies performance criteria such as flexural strength, chemical solubility, fired porosity, coefficient of expansion, glass transition temperature and metallo-ceramic bond characterisation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Creation
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3920 Porcelain tooth.
(a)
Identification. A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows a word that appears to be handwritten in white against a black background. The word is "Schottlander". The letters are connected, giving it a cursive appearance.
NOV 19 1996
510(K) Notification for Matchmaker/Propaque Porcelain
- 510(K) Summary of the safety and effectiveness information upon which the substantial equivalence determination for Matchmaker/Propaque porcelains are based
Name of contact person: | Mr B D Schottlander |
---|---|
Date that Summary was prepared | 16 February 1996 |
Trade name | Matchmaker/Propaque porcelains |
Common name Classification name
maker/Propaque por Bonding porcelain or metallo ceramic 872.6660-porcelain powder for clinical use
The legally marketed device to which we are claiming equivalence is called Creation.
The device is a feldspathic porcelain supplied for fusing to a metal sub-structure to form an aesthetic restoration which is then fitted as a crown or bridge.
Comparison to predicate device.
Chemical Similarities
Both products are feldspathic porcelains conforming to ISO 9693:1991 and are used in dentistry for fusing to a metal frame work to form an enamel porcelain layer. Both products are supplied with different layers ie; opaque, dentine, enamel etc. in order to replicate different colour layers in a natural tooth. Both products fall within the same class and part numbers. Both products are claimed on the labelling and directions for use to have essentially the same properties and usage.
Application Similarities
Both products are supplied as a powder for mixing together with a liquid to form a paste or as a pre-mixed paste. Both products are supplied with different layers ie; opaque, dentine, enamel etc. in order to replicate different colour layers in a natural tooth and these layers are built up and fired in a furnace in the same order and at similar temperatures (see also below).
Performance similarities.
Both products have essentially the same firing characteristics including low temperature for insertion into the furnace, drying time, final temperature and requirement for vacuum. Both products are manufactured to conform to ISO 9693:1991 Dental Ceramic Fused to Metal Restorative Material. This standard specifies performance criteria such as flexural strength, chemical solubility, fired porosity, coefficient of expansion, glass transition temperature and metallo-ceramic bond characterisation.
From the above information it is concluded that Matchmaker/Propaque porcelain possess substantial equivalence to the predicate device.