(139 days)
No
The summary describes a material (zirconia discs and coloring liquids) used in CAD/CAM milling for dental prostheses, with no mention of AI or ML capabilities.
No.
The device is used for the production of all-ceramic crowns, partial crowns and bridges, which are prosthetic devices, not therapeutic.
No.
The device is a restorative material used for the production of dental prostheses and coloring liquids, not a device designed to diagnose conditions or diseases.
No
The device description clearly states it is a physical material (zirconia discs) and coloring liquids used in the fabrication of dental prostheses. It does not describe any software component as the primary medical device.
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 dental prostheses (crowns, partial crowns, and bridges) for use in the mouth. This is a restorative dental application, not a diagnostic test performed on samples taken from the body.
- Device Description: The device consists of zirconia discs and coloring liquids used to fabricate these dental prostheses. This aligns with a material used for manufacturing medical devices, not for performing diagnostic tests.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies focus on material properties like flexural strength, chemical solubility, and biocompatibility, which are relevant to the safety and efficacy of a dental restorative material, not a diagnostic test.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on creating a physical restoration for dental purposes.
N/A
Intended Use / Indications for Use
Zenostar MT (medium translucency) are machinable zirconium oxide discs for the production of all-ceramic crowns, partial crowns and bridges in the anterior and posterior region.
Zenostar MT Color Liquids are ready-made, water-based solutions for shading full-contour restorations made from Zenostar MT. They are applied prior to sintering using the brush technique.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Zenostar MT are zirconia discs with 98.5mm width and 2 thicknesses, 14 mm and 18 mm. for use in the fabrication of dental prosthesis through the CAD/CAM milling technology. In addition, coloring liquids for shading full-contour restorations made from Zenostar MT.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior and posterior region (dental)
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 device has been designed and tested in accordance with ISO 6872:2008 Dentistry: Ceramic Materials for Flexural Strength, Chemical Solubility, Co-efficient of thermal expansion and Radioactivity. The product-specific standard ISO 6872:2008 specifies for a Class 5 material for three-unit prostheses involving molar restoration a minimum mean flexural strength of 500 MPa. Zenostar MT fulfills these criteria. The test results are equivalent to those of the predicate device. Zenostar MT. Zenostar MT Color Liquids have been thoroughly assessed for biocompatibility in accordance with EN ISO 10993-1:2009 Biological assessment of medical devices, EN ISO 7405:2008 Dentistry – Evaluation of biocompatibility of medical devices used in dentistry, and EN ISO 14971:2012 "Medical devices – Application of risk management to medical devices The biocompatibility is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength: >550 MPa
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2015
Wieland Dental + Technik Gmbh & Co. Kg % Donna Hartnett Director QA/Regulatory Affairs Ivoclar Vivadent. Inc. 175 Pineview Drive Amherst. New York 14228
Re: K152118
Trade/Device Name: Zenostar MT, Zenostar MT Color Liquids Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: November 13, 2015 Received: November 16, 2015
Dear Ms. Donna 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.
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
1
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 devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Susan Runno DDS, MA
Erin Keith Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152118
Device Name ZENOSTAR MT
Indications for Use (Describe)
Zenostar MT (medium translucency) are machinable zirconium oxide discs for the production of all-ceramic crowns, partial crowns and bridges in the anterior and posterior region.
Zenostar® MT Color Liquids are ready-made, water-based solutions for shading full contour restorations made from Zenostar MT. They are applied prior to sintering using the brush technique.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image contains the logo for Wieland Dental. The word "WIELAND" is written in large, bold, blue letters. Below that, the word "DENTAL" is written in smaller, blue letters.
EMBER OF THE IVOCLAR VIVADENT GR
Contact: Donna Marie Hartnett
Wieland Dental + Technik GMBH & Co KG Company: Lindenstrasse 2 71175 Pforzheim, Germany
December 15, 2015 Date Prepared:
Zenostar MT Proprietary Name:
Classification Name: Powder, Porcelain (872.6660) (Classification Code EIH)
- Primary predicate: IPS e.max CAD/IPS e.max ZirCAD (K051705) Predicate Device: by Ivoclar Vivadent, AG (Liechtenstein) Reference device: Zenotec Zr Bridge, Zenostar Zr Translucent, Zenotec Color Zr, Zenostar Color Zr, by Wieland Dental (K112710).
Device Description: Zenostar MT are zirconia discs with 98.5mm width and 2 thicknesses, 14 mm and 18 mm. for use in the fabrication of dental prosthesis through the CAD/CAM milling technology. In addition, coloring liquids for shading full-contour restorations made from Zenostar MT.
Indications for Use:
Zenostar MT (medium translucency) are machinable zirconium oxide discs for the production of all-ceramic crowns, partial crowns and bridges in the anterior and posterior region.
Zenostar MT Color Liquids are ready-made, water-based solutions for shading full-contour restorations made from Zenostar MT. They are applied prior to sintering using the brush technique.
Comparison to Predicate: The predicate device to which Zenostar MT has been compared is IPS e.max ZirCAD (K051705) and Zenostar MT Coloring Liquids have been compared to those in the predicate Zenotec Zr Bridge, Zenostar Zr Translucent, Zenotec Color Zr. Zenostar Color Zr, by Wieland Dental (K112710). All the ingredients except three nitrates in the coloring liquids have been used in the predicates. The biocompatibility of the new coloring liquid formulation was fully assessed and found to be equivalent to that of the predicate. For this application, Zenostar MT has been compared to its predicate with regard to chemical composition, performance data and indications for use. The comparison shows that Zenostar MT is substantially equivalent to the predicate device.
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Image /page/4/Picture/1 description: The image shows the logo for Wieland Dental. The word "WIELAND" is in large, bold, blue letters. Below that, in smaller blue letters, is the word "DENTAL" with a trademark symbol.
a member of the ivoclar vivadent group
| Device Name | Zenostar MT
K152118 | Primary Predicate
IPS e.max CAD/IPS
e.max ZirCAD
K051705 | Reference Device
Zenotec Zr Bridge,
Zenostar Zr Translucent,
Zenotec Color Zr,
Zenostar Color Zr
K112710 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Weiland Dental + Technik
GmbH & Co. KG | Ivoclar Vivadent, AG | Weiland Dental + Technik
GmbH & Co. KG |
| 510K Number | K152118 | K051705 | K112710 |
| Product Code | EIH | EIH | EIH |
| Indications for Use | Zenostar MT (medium
translucency) are
machinable zirconium
oxide discs for the
production of all- ceramic
crowns, partial crowns
and bridges in the anterior
and posterior region.
Zenostar MT Color
Liquids are ready-
made, water-based
solutions for shading
full-contour restorations
made from Zenostar MT.
They are applied prior to
sintering using the brush
technique. | IPS e.max CAD is a
CAD/CAM machinable
glass ceramic based on
lithium disilicate for the
preparation of full ceramic
crowns, inlays, onlays and
full ceramic 3-unit anterior
bridges.
IPS e.max ZirCAD
consists of machinable
zirconia blocks for the
preparation of full ceramic
crowns, onlays and 3- and
4-unit bridges and inlay
bridges (anterior and
molar). | Zeno Zr Disc is a group of
medical devices, which is
intended to fabricate all-
ceramic dental
restorations like crowns
and bridges. It consists of
ceramic blanks and
coloring liquids. Zenotec
Zr Bridge and Zenostar Zr
Translucent are yttria
stabilized zirconium
dioxide (Y-TZP) ceramic
(zirconia) blanks for the
CAD/CAM production of
dental restorations.
Zenotec Color Zr and
Zenostar Color Zr are
coloring liquids for the
shading of white zirconia
ceramic materials. The
products are intended to
be used by dental
technicians for fabrication
of all-ceramic single-tooth
and bridgework
restorations, with one or
two pontics, in the anterior
as well as in the posterior
tooth region |
| Contraindicated Use
of Device | Zenostar MT Bridge restorations with more than 3 units Very deep sub-gingival preparations Patients with substantially reduced residual dentition Bruxism Extended bridges Any other use no listed in the indications Temporary insertion | IPS e.max CAD Full veneers on molar crowns Very deep sub gingival preparations Patients with substantially reduced residual dentition bruxism any other use not listed in the indications IPS e.max ZirCAD | N/A |
| | Zenostar MT Color Liquids | | |
| | - All applications which are not listed in the labeling are considered as contraindications. | - Very deep sub gingival preparations Patients with substantially reduced residual dentition Bruxism | |
| Delivery Forms | 98.5mm discs
Coloring Liquids packaged in bottles | Any other use not listed in the labeling
Machinable blocks in various sizes with attached mandrel to fit milling machine | 98.5 mm discs
Zenostar Color Zr liquids packaged in bottles |
| Design Parameters | | | |
| Minimum Wall
Thickness | Zenostar MT for 3 unit anterior bridges:
Minimum wall thickness 1.2mm
Zenostar MT for 3 unit posterior bridges:
Minimum wall thickness 1.5mm | IPS e.max CAD for 3 unit anterior bridges:
Minimum wall thickness circular 1.2mm
Minimum wall thickness incisal/occlusal 1.5mm staining technique, 0.8mm cut-back technique
IPS e.max ZirCAD for 3 unit posterior bridges:
Minimum framework dimension circular 0.5mm
Minimum wall thickness occlusal 0.7mm | N/A |
| Minimum Connector
Dimension | Anterior Bridges:
Minimum Connector dimension 12mm²
Posterior Bridges
Minimum Connector dimension 16mm² | IPS e.max CAD:
Minimum Connector dimension 16mm²
IPS e.max ZirCAD:
Minimum Connector dimension 9mm² | N/A |
| Classification | Type II Class 5 | IPS e.max CAD:
Type II Class 3/3
IPS e.max ZirCAD:
Type II Class 6 | N/A |
| Biocompatibility | ISO 10993 and ISO 7405 | ISO 10993 and ISO 7405 | N/A |
| CAD/CAM
Processing | Yes | Yes | Yes |
| Physical Properties | | | |
| Flexural Strength | >550 MPa | IPS e.max CAD:
360 MPa
IPS e.max ZirCAD
900 MPa | N/A |
| Mechanical Testing | ISO 6872:2008 | ISO 6872:2008 | ISO 6872:2008 |
| Sterile | No | No | No |
| Reusable | No | No | No |
| Principles of
Operation | Zenostar MT milling discs
are supplied in a partly
sintered state. They are
processed in the Wieland
Zenotec milling machine
using dry machining. Final
sintering takes place after
milling in a compatible
sintering furnace. The
Ivoclar Vivadent
Programat S1 sintering
furnace or the Wieland
Zenotec System sintering
furnace are
recommended.
Prior to sintering the
Zenostar MT restorations
can be infiltrated with
Zenostar MT Color Liquids
using the brush technique
to achieve individual
shades.
The dental restoration can
be conventionally
cemented using either
phosphate cement or
glass ionomer cement or
adhesively using a
composite based
adhesive. Ivoclar Vivadent
recommends using
Multilink® Automix for
adhesive cementation,
SpeedCEM® for self-
adhesive cementation and
Vivaglass®CEM PL for
conventional cementation. | IPS e.max CAD:
Pre-crystallized
blocks
ready to be processed in a
compatible
CAD/CAM
milling machine.
IPS e.max ZirCAD
Blocks are supplied in a
partly-sintered state. They
are processed in a
compatible milling machine
using wet machining. Final
sintering takes place after
milling in a compatible
sintering
furnace.
The
Ivoclar Vivadent Programat
S1 sintering furnace is
recommended.
The dental restoration can
be
conventionally
cemented using either
phosphate c e m e n t or
glass ionomer cement or
adhesively using a
composite-based
adhesive. | Zenostar Zr Translucent
are
partly-sintered
zirconium milling discs
processed using dry
machining. Final sintering
takes place after milling.
Zenostar Color Zr liquids
are used prior to sintering
to infiltrate the zirconia
restorations using the
brush technique to
achieve individual shades. |
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Image /page/5/Picture/1 description: The image shows the logo for Wieland Dental. The word "WIELAND" is in large, bold, blue letters. Below that, the word "DENTAL" is in smaller, blue letters.
a member of the ivoclar vivadent group
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Image /page/6/Picture/1 description: The image shows the logo for Wieland Dental. The logo is in blue and consists of the word "WIELAND" in large, bold letters, with the word "DENTAL" in smaller letters below it. The logo is simple and modern, and the blue color gives it a professional look.
A MEMBER OF THE IVOCLAR VIVADENT GROUP
The predicate includes IPS e.max CAD which is a silicate-based dental ceramic and IPS e.max ZirCAD which is zirconium oxide. Zenostar MT is zirconium oxide. The composition of the zirconium materials is very similar. IPS e.max ZirCAD and Zenostar MT do not contain pigments. It is possible to achieve esthetic restorations with IPS e.max ZirCAD by veneering them using IPS e.max Ceram. To achieve aesthetic restorations with Zenostar MT the milled restoration is infiltrated with Zenostar MT Color Liquids before sintering. Zenostar MT Color liquids are ready-made, water-based solutions for shading full-contour restorations made from Zenostar MT. The shades are as follows: A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4,
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Image /page/7/Picture/1 description: The image shows the logo for Wieland Dental. The logo is in blue and consists of the word "WIELAND" in large, bold letters. Below the word "WIELAND" is the word "DENTAL" in smaller letters. There is a trademark symbol to the right of the word "DENTAL".
EMBER OF THE IVOCLAR VIVADENT GRO
Testing Summary: The device has been designed and tested in accordance with ISO 6872:2008 Dentistry: Ceramic Materials for Flexural Strength, Chemical Solubility, Co-efficient of thermal expansion and Radioactivity. The product-specific standard ISO 6872:2008 specifies for a Class 5 material for three-unit prostheses involving molar restoration a minimum mean flexural strength of 500 MPa. Zenostar MT fulfills these criteria. The test results are equivalent to those of the predicate device. Zenostar
MT. Zenostar MT Color Liquids have been thoroughly assessed for biocompatibility in accordance with EN ISO 10993-1:2009 Biological assessment of medical devices, EN ISO 7405:2008 Dentistry – Evaluation of biocompatibility of medical devices used in dentistry, and EN ISO 14971:2012 "Medical devices – Application of risk management to medical devices The biocompatibility is substantially equivalent to the predicate devices.
CONCLUSION: The indications, design parameters and physical properties of Zenostar MT lie between those of IPS e. max CAD and IPS e. max ZirCAD. Zenostar MT also includes Zenostar MT Color liquids which are applied to the milled restoration prior to sintering to achieve individual shades. This technique is already used as shown in the cleared Zenostar Zr Translucent predicate.
The above data and analysis demonstrates that Zenostar MT is substantially equivalent to the predicate device.