(139 days)
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.
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.
The provided text describes the regulatory clearance (K152118) for the Zenostar MT dental material, a zirconium oxide disc used for dental restorations, and its associated coloring liquids. The submission focuses on demonstrating substantial equivalence to predicate devices (IPS e.max CAD/IPS e.max ZirCAD and Zenotec Zr Bridge, Zenostar Zr Translucent, Zenotec Color Zr, Zenostar Color Zr).
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from ISO 6872:2008 for Class 5 material - 3 unit prostheses with molar restoration) | Reported Device Performance (Zenostar MT) |
|---|---|---|
| Flexural Strength | Minimum mean of 500 MPa | >550 MPa |
| Biocompatibility | In accordance with EN ISO 10993-1:2009, EN ISO 7405:2008, EN ISO 14971:2012 | Assessed and found equivalent to predicate devices |
2. Sample Size and Data Provenance for Test Set
The document does not explicitly state the sample size used for the mechanical and biocompatibility testing. The data provenance is implied to be from the manufacturer's internal testing (Wieland Dental + Technik GMBH & Co. KG), likely taking place in Germany. It is a prospective study as it's part of the device's clearance process.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish a "ground truth" in the typical sense of diagnostic imaging studies. The evaluation is based on objective, standardized physical and chemical tests (e.g., flexural strength, chemical solubility, biocompatibility).
4. Adjudication Method for Test Set
Not applicable, as this is not a study requiring adjudication of expert interpretations but rather laboratory testing against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a material science study, not an AI-assisted diagnostic imaging or human-in-the-loop performance study.
6. Standalone (Algorithm Only) Performance Study
Not applicable. There is no AI algorithm being evaluated in this submission.
7. Type of Ground Truth Used
The ground truth or benchmark used for evaluating the device's physical properties (like flexural strength) is the international standard ISO 6872:2008 for Dentistry: Ceramic Materials. For biocompatibility, the ground truth is established by adherence to standards like EN ISO 10993-1, EN ISO 7405, and EN ISO 14971.
8. Sample Size for Training Set
Not applicable. There is no AI algorithm with a training set.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no AI algorithm with a training set.
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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
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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 MTK152118 | Primary PredicateIPS e.max CAD/IPSe.max ZirCADK051705 | Reference DeviceZenotec Zr Bridge,Zenostar Zr Translucent,Zenotec Color Zr,Zenostar Color ZrK112710 |
|---|---|---|---|
| Manufacturer | Weiland Dental + TechnikGmbH & Co. KG | Ivoclar Vivadent, AG | Weiland Dental + TechnikGmbH & Co. KG |
| 510K Number | K152118 | K051705 | K112710 |
| Product Code | EIH | EIH | EIH |
| Indications for Use | Zenostar MT (mediumtranslucency) aremachinable zirconiumoxide discs for theproduction of all- ceramiccrowns, partial crownsand bridges in the anteriorand posterior region.Zenostar MT ColorLiquids are ready-made, water-basedsolutions for shadingfull-contour restorationsmade from Zenostar MT.They are applied prior tosintering using the brushtechnique. | IPS e.max CAD is aCAD/CAM machinableglass ceramic based onlithium disilicate for thepreparation of full ceramiccrowns, inlays, onlays andfull ceramic 3-unit anteriorbridges.IPS e.max ZirCADconsists of machinablezirconia blocks for thepreparation of full ceramiccrowns, onlays and 3- and4-unit bridges and inlaybridges (anterior andmolar). | Zeno Zr Disc is a group ofmedical devices, which isintended to fabricate all-ceramic dentalrestorations like crownsand bridges. It consists ofceramic blanks andcoloring liquids. ZenotecZr Bridge and Zenostar ZrTranslucent are yttriastabilized zirconiumdioxide (Y-TZP) ceramic(zirconia) blanks for theCAD/CAM production ofdental restorations.Zenotec Color Zr andZenostar Color Zr arecoloring liquids for theshading of white zirconiaceramic materials. Theproducts are intended tobe used by dentaltechnicians for fabricationof all-ceramic single-toothand bridgeworkrestorations, with one ortwo pontics, in the anterioras well as in the posteriortooth region |
| Contraindicated Useof 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 discsColoring Liquids packaged in bottles | Any other use not listed in the labelingMachinable blocks in various sizes with attached mandrel to fit milling machine | 98.5 mm discsZenostar Color Zr liquids packaged in bottles |
| Design Parameters | |||
| Minimum WallThickness | Zenostar MT for 3 unit anterior bridges:Minimum wall thickness 1.2mmZenostar MT for 3 unit posterior bridges:Minimum wall thickness 1.5mm | IPS e.max CAD for 3 unit anterior bridges:Minimum wall thickness circular 1.2mmMinimum wall thickness incisal/occlusal 1.5mm staining technique, 0.8mm cut-back techniqueIPS e.max ZirCAD for 3 unit posterior bridges:Minimum framework dimension circular 0.5mmMinimum wall thickness occlusal 0.7mm | N/A |
| Minimum ConnectorDimension | Anterior Bridges:Minimum Connector dimension 12mm²Posterior BridgesMinimum Connector dimension 16mm² | IPS e.max CAD:Minimum Connector dimension 16mm²IPS e.max ZirCAD:Minimum Connector dimension 9mm² | N/A |
| Classification | Type II Class 5 | IPS e.max CAD:Type II Class 3/3IPS e.max ZirCAD:Type II Class 6 | N/A |
| Biocompatibility | ISO 10993 and ISO 7405 | ISO 10993 and ISO 7405 | N/A |
| CAD/CAMProcessing | Yes | Yes | Yes |
| Physical Properties | |||
| Flexural Strength | >550 MPa | IPS e.max CAD:>360 MPaIPS 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 ofOperation | Zenostar MT milling discsare supplied in a partlysintered state. They areprocessed in the WielandZenotec milling machineusing dry machining. Finalsintering takes place aftermilling in a compatiblesintering furnace. TheIvoclar VivadentProgramat S1 sinteringfurnace or the WielandZenotec System sinteringfurnace arerecommended.Prior to sintering theZenostar MT restorationscan be infiltrated withZenostar MT Color Liquidsusing the brush techniqueto achieve individualshades.The dental restoration canbe conventionallycemented using eitherphosphate cement orglass ionomer cement oradhesively using acomposite basedadhesive. Ivoclar Vivadentrecommends usingMultilink® Automix foradhesive cementation,SpeedCEM® for self-adhesive cementation andVivaglass®CEM PL forconventional cementation. | IPS e.max CAD:Pre-crystallizedblocksready to be processed in acompatibleCAD/CAMmilling machine.IPS e.max ZirCADBlocks are supplied in apartly-sintered state. Theyare processed in acompatible milling machineusing wet machining. Finalsintering takes place aftermilling in a compatiblesinteringfurnace.TheIvoclar Vivadent ProgramatS1 sintering furnace isrecommended.The dental restoration canbeconventionallycemented using eitherphosphate c e m e n t orglass ionomer cement oradhesively using acomposite-basedadhesive. | Zenostar Zr Translucentarepartly-sinteredzirconium milling discsprocessed using drymachining. Final sinteringtakes place after milling.Zenostar Color Zr liquidsare used prior to sinteringto infiltrate the zirconiarestorations using thebrush technique toachieve 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.
§ 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.