(75 days)
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No
The summary describes a material (zirconia ceramics) used for dental prosthetics and its manufacturing process. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies focus on material properties and biocompatibility, not algorithmic performance.
No.
The device is a material for manufacturing dental prosthetics, not a device that directly treats or prevents a disease or condition for therapeutic benefit.
No
Explanation: The device is indicated for the production of artificial teeth and dental prosthetics, which are restorative rather than diagnostic in nature. Its description focuses on material processing for fabrication, and the performance studies mention physical, chemical, and biocompatibility testing, not diagnostic accuracy.
No
The device is a physical material (zirconia ceramic) used for fabricating dental prosthetics, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the production of artificial teeth and dental prosthetics. This is a medical device used for treatment and restoration within the body, not for diagnosing conditions by examining samples taken from the body.
- Device Description: The description details the material and manufacturing process for creating dental ceramics, which are physical components for dental work.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This device is a material used to create a physical restoration.
N/A
Intended Use / Indications for Use
Aidite Zirconia Dental Ceramics are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Product codes (comma separated list FDA assigned to the subject device)
EIH, ELL
Device Description
Aidite Zirconia Dental Ceramics are derived from zirconia powder that has been processed via uni-aixial die pressing, followed by iso-static pressing, to achieve various shapes of uniform density and distribution. The ceramic blocks can be fabricated into various prosthetic dental devices. Physical and mechanical properties for Aidite Zirconia Dental Ceramics are shown in Table 5-1 and are similar in nature to the predicate device. Aidite Zirconia Dental Ceramics are offered in seven (7) different product families of shapes and a multitude of different sizes as shown below in Figure 1 and Table 5-2 and are capable of being machined into complex dental shapes using modern machining methods, and are similar to the sizes and shapes of the predicate device. The one exception is the AS-XND System of blocks is pre-mounted on mandrels. Any difference in the net shapes and dimensions between Aidite Zirconia Dental Ceramics and those offered by the manufacturer of the predicate devices are incidental to the performance of the final dental prosthetic devices that will be fabricated from them.
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
Not Found
Intended User / Care Setting
Not Found
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)
Aidite Zirconia Dental Ceramics have been tested for their physical and chemical properties in accordance with ISO 6872 and BS EN 1641, as well as biocompatibility in accordance with ISO 10993-1. Clinical testing was not performed for Aidite Zirconia Dental Ceramics as part of the Pre-market Notification requirements for this submission, as dental ceramics that fall under FDA product code EIH have a long history of safe and effective use in the US. The raw materials used in Aidite Zirconia Dental Ceramics are identical to the raw material used in the predicate device and are sourced from the same raw material supplier in Japan, and do not raise any questions regarding their safety and effectiveness as compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
Image /page/0/Picture/0 description: The image shows the logo for Emergo Group. The logo consists of the word "EMERGO" followed by a stylized letter "E" inside of a circle. The word "GROUP" is to the right of the circle. The text is in a sans-serif font.
Zirconia Dental Ceramics
KII1291
JUL 200 2011
SECTION 5 - 510(k) SUMMARY
Submission Correspondent
Company Name: Company Address:
Company Contact:
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Submission Sponsor
Company Name: Company Address:
Country: Phone: Fax: Website:
Device Classification
Device Sponsor:
Device Trade Name:
Product Classification Name:
Product Code:
Regulation Name:
Regulation Number:
Classification Panel:
Emergo Group, Inc. 611 West 5th Street Third Floor Austin, TX 78701 Stuart R. Goldman Senior Consultant 512.600.7616 USA 512.327.9997 512.327.9998 April 22, 2011 www.emergogroup.com/
Qinhuangdao Aidite High-Technical Ceramics Co. 12 North of West Ring Road - Economic and Technological Development Zone Qinhuangdao City China 0086-335-8587898 0086-335-8587198 www.zro2blocks.com/
Qinhuangdao Aidite High-Technical Ceramics Co.
Aidite Zirconia Dental Ceramics
Powder, Porcelain
ElH
Porcelain powder for clinical use
872.6660
Dental Devices
1
EMERGO GROUP
Image /page/1/Picture/1 description: The image shows a world map in the background with the Aidite logo in the foreground. The Aidite logo is a black square with a white "A" in the center. The word "Aidite" is written in black letters below the square. To the right of the logo, the word "Zirconia" is written in black letters. The map appears to be a simplified representation of the continents.
Zirconia Dental Ceramics
Intended Use
Aidite Zirconia Dental Ceramics are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Predicate Device
Upcera Zirconia Blanks (K093560)
Device Description
Aidite Zirconia Dental Ceramics are derived from zirconia powder that has been processed via uni-aixial die pressing, followed by iso-static pressing, to achieve various shapes of uniform density and distribution. The ceramic blocks can be fabricated into various prosthetic dental devices. Physical and mechanical properties for Aidite Zirconia Dental Ceramics are shown in Table 5-1 and are similar in nature to the predicate device.
| Table 5-1
Physical & Mechanical Properties
| Aidite Zirconia Dental Ceramics | |
|---|---|
| ZrO₂ | 4% |
| HfO₂ | > 1% |
| Al₂O₃ |