(54 days)
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No
The device description focuses on the chemical composition and physical properties of dental porcelain materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as auxiliary products for a dental porcelain system used to create crowns, bridges, or dental prostheses, which are restorative rather than therapeutic.
No
The device description indicates it is a dental porcelain system used for creating crowns, bridges, or dental prostheses. Its components (frits, opacifiers, pigments) are materials for fabrication, not for detecting or diagnosing medical conditions.
No
The device description clearly states it contains mixtures of frits, opacifiers, and pigments, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the product is for use in creating dental prostheses (crowns, bridges) in conjunction with metal alloys. This is a dental restorative material, not a diagnostic test performed on biological samples.
- Device Description: The description details the composition of the materials (frits, opacifiers, pigments) and their use in creating different colors and properties for dental restorations. This aligns with the characteristics of dental porcelain.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information about a patient's health condition.
Therefore, the FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS are a dental device used for restorative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS are for use with the Finesse™ Low-Fusing Porcelain System in conjunction with non-precious or noble or high noble alloys when used for conventional porcelain-fused-to-metal crowns, bridges or dental prostheses.
Product codes
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Device Description
The FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS contain mixtures of frits, opacifiers and pigments in varied quantities to create an assortment of materials with a variety of fusion temperatures, translucencies and colors. They contain the same silicate frits and opacifiers, and some of the same pigments used in K954761. Additional pigments used are also used in predicate medical devices.
The physical properties for FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS meet the appropriate ISO Standards.
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
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Indicated Patient Age Range
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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
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.
0
510(k) SUMMARY
DENTSPLY
MAY 2 8 1996
NAME & ADDRESS:
DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax (717) 854-2343
P. J. Lehn Telefax (717) 849-4343
April 2, 1996 DATE PREPARED: P. Jeffery Lehn CONTACT : TRADE OR PROPRIETARY NAME: FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS 872.6660 Porcelain Powder for Clinical Use CLASSIFICATION NAME: Finesse™ Low-Fusing Porcelain System K954761 PREDICATE DEVICE:
The FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS DEVICE DESCRIPTION: contain mixtures of frits, opacifiers and pigments in varied quantities to create an assortment of materials with a variety of fusion temperatures, translucencies and colors. They contain the same silicate frits and opacifiers, and some of the same pigments used in K954761. Additional pigments used are also used in predicate medical devices.
The physical properties for FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS meet the appropriate ISO Standards.
The FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS are for INTENDED USE: use with the Finesse™ Low-Fusing Porcelain System in conjunction with non-precious or noble or high noble alloys when used for conventional porcelain-fused-to-metal crowns, bridges or dental prostheses.
TECHNOLOGICAL CHARACTERISTICS: The FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS consist of opaque modifiers, opaque correction, dentin correction and stains, and glaze porcelains. These porcelains are substantially equivalent to Finesse Low-Fusing Porcelains (K954761).
All of the components in the FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS have been used in predicate medical devices.
We believe that the prior use of the FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS components in predicate devices, the performance data, and the results of toxicity testing on the predicate device, support the safety and effectiveness of FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS for the intended uses.
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