(131 days)
Not Found
No
The description focuses on the material composition and manufacturing process of dental restoration blocks, with no mention of AI or ML capabilities.
No
The device, inCoris ZI, is described as blocks of zirconia ceramics used to create dental restorations like crowns and bridges, which are inert materials, not therapeutic. Its function is to be processed into a medical device, not to provide therapy itself.
No
The device, inCoris ZI, is described as blocks of zirconia ceramics used to create custom dental restorations through sintering and grinding. Its intended use is for fabricating dental crowns, bridges, and caps. There is no information suggesting it is used to diagnose diseases or conditions; rather, it is a manufacturing material for prosthetics.
No
The device description clearly states that the device is comprised of physical blocks of zirconia ceramics (ZrO2) used to create dental restorations. This is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this device is used to create dental restorations (crowns, bridges, etc.) that are placed in the mouth, not used to test samples from the body.
- The device description focuses on the material and manufacturing process of the dental blocks. It describes how the blocks are processed and used to create custom dental restorations.
- The performance studies focus on the mechanical properties and suitability of the dental restorations. They assess things like sintering, mechanical strength, fit, and color, which are relevant to the function of a dental restoration, not a diagnostic test.
Therefore, this device falls under the category of a dental prosthetic material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Classic sintering
- Framework and reduced crowns in the anterior and posterior tooth region
- Bridge frameworks in the anterior and posterior tooth region with max. 2 pontics
- Crown caps in the anterior and posterior region
- Cone and telescoping crowns .
Speed sintering
- Framework and reduced crowns in the anterior and posterior tooth region
- Bridge frameworks in the anterior and posterior tooth region with max. 2 pontics and up to 9 . units
- Crown caps in the anterior and posterior region
- Cone and telescoping crowns
Super speed sintering - Framework and reduced crowns with a maximum wall-thickness of 2 mm
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
The inCoris ZI are blocks of various sizes from which custom made dental restorations are grinded using Sirona CAD/CAM system. inCoris ZI ceramics constitute blocks comprised of zirconia ceramics (ZrO2). The blocks are initially manufactured in a partially sintered state; then, they are o individually processed to specification, and finally, densely sintered. One end plane of a block is mounted to a metal carrier that is inserted in the spindle's clamping chuck of the grinding machine. The blocks are available in different colors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior tooth region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sirona performed a series of tests to assess whether the device is appropriate for the indications for use. Sintering tests coupled with bench mechanical testing highlight that the mechanical properties are appropriate. Furthermore, crack damage inspection, restoration fit, color suitability, and overall usability tests were conducted.
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.
Not Found
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).
Not Found
§ 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
K.123.669
APR 0 8 2013
510(k) Summary for Sirona Dental Systems inCoris ZI
1. Sponsor
Sirona Dental Systems GmbH
Fabrikstrasse 31.
D-64625 Bensheim
Germany
Contact Person: Fritz Kolle
Telephone: +49 6251 16 3294
Date Prepared: March 05, 2013
Device Name 2.
Proprietary Name: inCoris ZI
Common/Usual Name: Powder, Porcelain
Classification Name: Porcelain powder for clinical use
3. Predicate Devices
inCoris ZI (K062509)
Intended Use 4.
Classic sintering
- · Framework and reduced crowns in the anterior and posterior tooth region
- . Bridge frameworks in the anterior and posterior tooth region with max. 2 pontics
- . Crown caps in the anterior and posterior region
- Cone and telescoping crowns .
Speed sintering
- . Framework and reduced crowns in the anterior and posterior tooth region
- · Bridge frameworks in the anterior and posterior tooth region with max. 2 pontics and up to 9 . units
- · Crown caps in the anterior and posterior region
- · Cone and telescoping crowns
Sirona Dental Systems 510(k) inCoris ZI
Page 1
APPENDIX F
1
Super speed sintering
- Framework and reduced crowns with a maximum wall-thickness of 2 mm
న. Device Description and Function
The inCoris ZI are blocks of various sizes from which custom made dental restorations are grinded using Sirona CAD/CAM system. inCoris ZI ceramics constitute blocks comprised of zirconia ceramics (ZrO2). The blocks are initially manufactured in a partially sintered state; then, they are o individually processed to specification, and finally, densely sintered. One end plane of a block is mounted to a metal carrier that is inserted in the spindle's clamping chuck of the grinding machine. The blocks are available in different colors.
6. Scientific Concept
The underlying scientific concept is
- . Processing dental restorations by Sirona Dental CAD/CAM System
- . Restorations are grinded from an inCoris ZI block by a Sirona CAM machine
- . Different sintering time to gain appropriate material properties
7. Physical and Performance Characteristics
7.1. Design
The design of the inCoris ZI is described in section 5, Device Description and Function.
7.2. Material Used
inCoris ZI ceramics constitute blocks comprised of zirconia ceramics (ZrO2). One end plane of a block is mounted to a metal carrier that is inserted in the spindle's clamping chuck of the grinding machine. The material is biocompatible according to ISO 10993-1: 2009, "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process".
7.3. Physical Properties
Final technical data of densely sintered inCoris ZI.
| Density: | $\geq$ 6.05 g cm-3 |
|---|---|
| Thermal expansion | |
| coefficient (20 - 500 °C): | 11.0 10-6 K-1 |
| Bending strength: | > 1100 MPa |
Sirona Dental Systems 510(k) inCoris ZI
Page 2
APPENDIX F
7.4. Chemical Properties
2
| Component | inCoris ZI |
|---|---|
| ZrO2+HfO2+Y2O3 | ≥ 99.0% |
| Y2O3 | 5.2% |
| HfO2 | 2% |
| Al2O3 |