(111 days)
No
The device description and performance studies focus on the physical properties and chemical composition of dental ceramic materials, with no mention of AI or ML.
No
The device is a dental material used for staining, characterizing, and glazing ceramic dental prosthetics, not for treating a disease or condition. Its use is limited to dental technicians for cosmetic and functional finishing of dental ceramics.
No
The device description indicates that IPS Ivocolor is a universal stains and glaze assortment for ceramic materials, used by dental technicians. Its intended use is for "Staining and/or characterization and glazing of ceramic materials," which is a material processing function, not a diagnostic one. Diagnostic devices are used to detect, diagnose, treat, or prevent disease. This device modifies dental materials.
No
The device description clearly outlines a physical assortment of dental materials (porcelain powders, liquids, etc.) used for staining and glazing ceramic materials. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Staining and/or characterization and glazing of ceramic materials" used in dental restorations. This is a process performed on materials outside of the human body to modify their appearance and properties.
- Device Description: The device consists of stains, glazes, and liquids used to color and finish dental ceramic materials. These are materials applied to the dental restoration itself, not used to test or analyze a sample from the human body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It is purely for the aesthetic and functional finishing of dental prosthetics.
- Intended User: The intended user is a "Dental technician," who works in a lab setting to create and finish dental restorations, not typically involved in diagnostic testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Staining and/or characterization and glazing of ceramic materials from Ivoclar Vivadent and Wieland Dental.
- Veneering ceramics
- Press ceramics
- Milling ceramics
- Zirconium oxide (frameworks and full-contour restorations)
Product codes
EIH
Device Description
IPS Ivocolor is a universal stains and glaze assortment consisting of 23 shades of Essence porcelain, 9 shades of Dentin porcelain, 3 incisal porcelains, 2 Glaze powders, 2 glaze pasts, 2 Mixing Liquids, Essence fluid and shade guides. The range of products has been coordinated with the layering, press and CAD Ceramics from Ivoclar Vivadent and the zirconium oxides from Wieland Dental and be used regardless of the CTE of the ceramic. The difference is that IPS Ivocolor can be used with both metal-ceramic and fullceramic materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The product has been tested to ISO 6872 and meets the requirements.
IPS Ivocolor is the same Type and Class material as the primary predicate.
The device has been tested for the following physical properties according to ISO 6872:
Uniformity Cleanliness Radioactivity of ceramic Color Coding Flexural Strength Coefficient of Linear Thermal Expansion Glass Transition Temperature Chemical Solubility
The CTE and Glass transition temperature for IPS Ivocolor are slightly lower than those of the primary predicate. This is to ensure that the new materials are compatible with the chosen range of ceramics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
IPS 99 One and IPS 99 Ceram (K121359)
Reference Device(s)
Eris Layering Materials (K012174)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The symbol is composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2015
Ivoclar Vivadent AG c/o Ms. Donna Hartnett Director OA/Regulatory Affairs Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, New York 14228
Re: K151894
Trade/Device Name: IPS Ivocolor Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: September 18, 2015 Received: September 21, 2015
Dear Ms. Hartnett:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151894
Device Name IPS IVOCOLOR
Indications for Use (Describe)
Staining and/or characterization and glazing of ceramic materials from Ivoclar Vivadent and Wieland Dental.
- Veneering ceramics
- Press ceramics
- Milling ceramics
- Zirconium oxide (frameworks and full-contour restorations)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(K) SUMM Revised IPS Ivocolor
Image /page/3/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in blue, with the words "passion vision innovation" written in smaller letters below. Above the company name are green and blue dots and squares. The logo is simple and modern, and it conveys a sense of professionalism and innovation.
| Contact: | Donna Marie Hartnett |
|---|---|
| Company: | Ivoclar Vivadent, AG |
| Bendererstrasse 2, Schaan, FL-9494, Liechtenstein | |
| +423-235-3535 | |
| Date Prepared: | October 27, 2015 |
| Proprietary Name: | IPS Ivocolor |
| Classification Name: | Powder, Porcelain CFR Regulation (872.6660) |
| (Classification Code EIH) | |
| Predicate Device: | IPS 99 One and IPS 99 Ceram (K121359) (primary) |
| Eris Layering Materials (K012174) (reference only) |
Device Description: IPS Ivocolor is a universal stains and glaze assortment consisting of 23 shades of Essence porcelain, 9 shades of Dentin porcelain, 3 incisal porcelains, 2 Glaze powders, 2 glaze pasts, 2 Mixing Liquids, Essence fluid and shade guides. The range of products has been coordinated with the layering, press and CAD Ceramics from Ivoclar Vivadent and the zirconium oxides from Wieland Dental and be used regardless of the CTE of the ceramic. The difference is that IPS Ivocolor can be used with both metal-ceramic and fullceramic materials.
Indications for Use:
Staining and/or characterization and glazing of ceramic materials from Ivoclar Vivadent and Wieland Dental:
- Veneering ceramics -
- Press ceramics -
- -Milling ceramics
- Zirconium oxide (frameworks and full-contour restorations) -
Comparison to Predicate: The primary predicate devices to which IPS Ivocolor has been compared are IPS 99 One and IPS 99 Ceram (K121359). Eris Layering Materials (K012174) have also been used as a reference. Ivocolor's indication for individualized staining, characterization and glaze of ceramic materials is the same as IPS 99 shades, stains and glaze. For this application, IPS Ivocolor has been compared to its primary predicate with regard to the chemical compositions, physical properties, operating principals and indications for use. The comparison shows that IPS Ivocolor is substantially equivalent to the primary predicate device.
4
510(K) SUMMARY
Image /page/4/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized blue font, with the words "passion vision innovation" written in a smaller font below. Above the company name, there is a series of green and blue dots and squares arranged in an arc shape. The logo is clean and modern, reflecting the company's focus on innovation in the dental industry.
| Indications for Use | Predicate device
IPS 99 Ceram (K121359) | IPS Ivocolor |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The IPS 99 system contains shades,
stains and glaze materials used for the
characterization of metal ceramic
restorations.
In addition:
IPS 99 Ceram is a conventional multi-
layer veneering ceramic for the
fabrication of metal-ceramic restorations
using the most popular dental alloys in
the CTE range of 13.8-15.0 x10-6/K (25-
500°C).
IPS 99 One is a one-layer veneering
ceramic for the fabrication of metal-
ceramic restorations using the most
popular dental alloys in the CTE range of
13.8-15.0 x10-6/K (25-500°C).
IPS 99 is intended to be used for inlays,
onlays, veneers and anterior/posterior
PFM crowns.
As a reference device, the Eris system
includes shades, stains and glaze
materials (currently sold under the brand
name IPS Empress Universal) which are
used for the characterization of all-
ceramic restorations.
In addition, Eris layering materials are
porcelain powders used in the pressable
ceramic system Empress 2, which is
used for metal free single unit, and
multiple unit bonded crown and bridge
restorations. | Staining and/or characterization and glazing
of ceramic materials from Ivoclar Vivadent
and Wieland Dental:
- Veneering ceramics
- Press ceramics
- Milling ceramics
- Zirconium oxide (framework and full-
contour) |
| Summary
Indications | IPS Ivocolor is a universal stains and glaze assortment. Its indication for
individualized staining, characterization and glaze of ceramic materials is the same as
IPS 99 shades, stains and glaze. IPS Ivocolor Essence are shade materials.
The difference is that IPS Ivocolor can be used with both metal-ceramic and full-
ceramic materials whereas the primary predicate - IPS 99 shades, stains and glaze -
was supplied as part of the IPS 99 system for metal-ceramic and the reference device
- Eris Layering Materials - shade, stains and glaze were supplied as part of the Eris
system for full-ceramics | |
| Working principle | IPS 99 shades and stains are used in very
small amounts and thin layers to
customize the esthetics of a restoration.
The glaze is used for the glaze firing to
achieve a shiny surface.
Compatible with IPS 99, IPS InLine, IPS
InLine PoM. | The Essence and Stains are used in very
small amounts and thin layers to
customize the aesthetic of a restoration.
The Glaze is used for the glaze firing to
achieve a shiny surface.
Compatible with:
IPS e.max Press
IPS e.max CAD (crystalised)
IPS e.max Ceram |
| | The reference device - Eris Layering
Materials - shades and stains are used in
very small amounts and thin layers to
customize the aesthetics of a restoration.
The glaze is used for the glaze firing to
achieve a shiny surface.
Compatible with IPS Empress CAD, IPS
Empress Esthetic | IPS e.max ZirPress
IPS e.max ZirCAD (sintered)
IPS Empress CAD
IPS Empress Esthetic
IPS Style
IPS InLine
IPS d.SIGN
IPS Classic
Zenostar (sintered) |
| Summary Working
Principle | The working principle of the new product is the same as the primary predicate
device and the reference device. The significant difference is that IPS
Ivocolor will be marketed for use with the whole range of ceramic materials
from Ivoclar Vivadent AG and the zirconium oxide ceramic material from
Wieland Dental+Technik GmbH.
This is a benefit to the dental technician because he can use a universal
product.
In the past each brand of ceramic was supplied in a system and had its own
shades, stains and glaze. | |
| | Technically it was not difficult to develop shade, stains and glaze which are
compatible with a range of ceramics because the material is applied in very
small quantities and very thin layers. The potential tension which can be
developed between the shade, stains and glaze and the ceramic materials is
minimal and does not cause a compatibility problem. It was only necessary to
ensure that the CTE of the shade, stains and glaze is not above that of the
ceramic material and this has been achieved. | |
| Summary
Composition | The key ingredients, the silica-based dental glass ceramic are the same as
the primary predicate device. IPS Ivocolor includes a new pigment. The
biocompatibility of the new formulation was fully assessed and is equivalent to
IPS 99 | |
| Physical Properties | The product has been tested to ISO 6872 and meets the requirements. | The product has been tested to ISO 6872 and meets the requirements.
IPS Ivocolor is the same Type and Class material as the primary predicate.
The device has been tested for the following physical properties according to ISO 6872:
Uniformity Cleanliness Radioactivity of ceramic Color Coding Flexural Strength Coefficient of Linear Thermal Expansion Glass Transition Temperature Chemical Solubility |
| Summary Physical properties | The CTE and Glass transition temperature for IPS Ivocolor are slightly lower than those of the primary predicate. This is to ensure that the new materials are compatible with the chosen range of ceramics. | |
5
510(K) SUMMARY
Image /page/5/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in blue, with the words "passion vision innovation" written in smaller font below. Above the company name are a series of green and blue dots. The logo is simple and modern, and it conveys a sense of innovation and quality.
6
510(K) SUMM Revise
IPS Ivocolor
Image /page/6/Picture/2 description: The image is the logo for Ivoclar Vivadent. The logo is blue and green. The words "Ivoclar Vivadent" are in blue, with the first word on top of the second. Below the second word are the words "passion vision innovation" in red.
Conclusion:
IPS Ivocolor is a ceramic material to stain, characterize and glaze ceramic restorations. It is compatible with several ceramic materials, both metal-ceramic and full-ceramic which is a benefit for the user. The indications, performance and biocompatibility match those of existing products, including the primary predicate IPS 99 and the reference device Eris Layering Materials.
Therefore IPS Ivocolor is substantially equivalent to the primary predicate device, IPS 99 One and IPS 99 Ceram (K121359).