(265 days)
Dental ceramic restorations made from ADAMANT ZIRCONIA DISC are indicated for crowns and multi-unit bridges (up to a maximum of three elements). Applications include both anterior and posterior regions.
The ADAMANT ZIRCONIA DISC is a ceramic block, composed of partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) (Y-TZP) that can be cut/milled for forming dental restorations such as crowns and bridges (up to a maximum of three elements). Applications include both anterior and posterior regions. The ADAMANT ZIRCONIA DISC is designed for milled production on commercial CAD/CAM systems. After milling the disc, it is final sintered, so the Zirconia Disc is transformed into the object as dental restorations.
The provided text describes a 510(k) premarket notification for the "ADAMANT ZIRCONIA DISC," a dental ceramic material. This means the filing is to demonstrate substantial equivalence to existing legally marketed devices, rather than a de novo approval requiring extensive clinical efficacy trials. Therefore, the information provided focuses on non-clinical performance data and comparison to predicate devices, not on detailed acceptance criteria for a diagnostic AI device or a comparative effectiveness study with human readers.
Based on the provided document, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a typical "acceptance criteria" table for a diagnostic AI device. Instead, it details performance criteria against international standards for dental ceramic materials and biocompatibility:
| Acceptance Criteria (Standard Requirement) | Reported Device Performance (ADAMANT ZIRCONIA DISC) |
|---|---|
| Biocompatibility (ISO 10993) | |
| Cytotoxicity test | Passed (No cytotoxic effect) |
| Intracutaneous reactivity in rabbits | Passed (Met test requirements) |
| Skin Sensitization Study in the Guinea Pig (Maximization Method) | Passed (No skin sensitization produced) |
| Genotoxicity: Bacterial Reverse Mutation Study | Passed (Test article extracts nonmutagenic) |
| Material Performance (ISO 6872:2008, Dentistry Ceramic materials) | |
| Uniformity of the material | Passed |
| Freedom from extraneous materials | Passed |
| Physical and chemical properties: Activity concentration of uranium 238 | Passed |
| Physical and chemical properties: Thermal expansion coefficient | Passed |
| Physical and chemical properties: Flexural Strength | Passed (515 MPa – 1349 MPa) |
| Physical and chemical properties: Chemical solubility | Passed |
| Density (after sintering) | 6.04 ~ 6.33 g/cm³ (Acceptance criteria implied by predicate comparison as ≥ 6.0 g/cm³) |
| Chemical Composition (e.g., ZrO2 + HfO2 + Y2O3 [wt%]) | ≥ 99.0 (Acceptance criteria implied by predicate comparison) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify sample sizes for individual tests. It refers to "non-clinical testing" and lists various tests, but without quantifying the number of samples or specimens used for each. There is no information regarding data provenance (country of origin, retrospective/prospective), as these are material property tests rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This section is not applicable to this device. The ADAMANT ZIRCONIA DISC is a material for dental restorations, not a diagnostic device requiring expert interpretation or ground truth establishment based on clinical judgment. The "ground truth" for its performance is determined by adherence to scientific and engineering standards (ISO 10993, ISO 6872) through physical and chemical laboratory tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable. The tests performed are laboratory-based material characterizations, not assessments requiring expert adjudication of clinical findings.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a dental ceramic material, not an AI-powered diagnostic system. No human reader studies, with or without AI assistance, were performed or are relevant to its approval.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance of the ADAMANT ZIRCONIA DISC is based on established international standards for dentistry ceramic materials (ISO 6872) and biological evaluation of medical devices (ISO 10993). These standards define the acceptable physical, chemical, and biological properties a material must possess. The "ground truth" is therefore derived from the specifications and testing methodologies outlined in these widely recognized standards.
8. The sample size for the training set:
This is not applicable. The ADAMANT ZIRCONIA DISC is a material, not a machine learning model. There is no "training set."
9. How the ground truth for the training set was established:
This is not applicable. As there is no training set for a material, there is no ground truth established for it in this context.
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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 is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 19, 2016
Adamant Co., Ltd. % Deborah Grayeski Sr. Project Manager M Squared Associates 575 Eighth Ave, Suite 1212 New York, New York 10018
Re: K160203
Trade/Device Name: ADAMANT ZIRCONIA DISC Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: September 14, 2016 Received: September 15, 2016
Dear Deborah Grayeski:
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 801and Part 809); 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 and Part 809), 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting 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) K160203
Device Name ADAMANT ZIRCONIA DISC
Indications for Use (Describe)
Dental ceramic restorations made from ADAMANT ZIRCONIA DISC are indicated for crowns and multi-unit bridges (up to a maximum of three elements). Applications include both anterior and posterior regions.
| 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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510(k) Number: K160203
510(k) Summary
In accordance with 21 CFR 807.92, the following summary of information is provided:
| Sponsor: | Adamant Co., Ltd.1-16-7 Shinden, Adachi KuTokyo, 123-8595, JapanTel: 81-3-3919-1171Fax: 81-3-3913-3434 |
|---|---|
| Contact: | Deborah Lavoie-GrayeskiM Squared Associates575 Eighth Avenue, Suite 1212New York, NY 10018Ph: 703-562-9800 x250Fax: 703-562-9797Email: dgrayeski@msquaredassociates.com |
| Date prepared: | October 18, 2016 |
| Regulatory Class: | Class II |
| Proprietary Name: | ADAMANT ZIRCONIA DISC |
| Common Name: | Powder, Porcelain |
| Classification Name: | Porcelain powder for clinical use |
| Regulation Number: | 21 CFR 872.6660 |
| Product Codes: | EIH |
| Predicate Devices: | Cercon® Base, K051462DD cubeX2, K150196 |
Indication for Use:
Dental ceramic restorations made from ADAMANT ZIRCONIA DISC are indicated for crowns and multiunit bridges (up to a maximum of three elements). Applications include both anterior regions.
Device Description:
The ADAMANT ZIRCONIA DISC is a ceramic block, composed of partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) (Y-TZP) that can be cut/milled for forming dental restorations such as crowns and bridges (up to a maximum of three elements). Applications include both anterior and posterior regions. The ADAMANT ZIRCONIA DISC is designed for milled production on commercial CAD/CAM systems. After milling the disc, it is final sintered, so the Zirconia Disc is transformed into the
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object as dental restorations.
Principle of Operation:
ADAMANT ZIRCONIA DISC is derived from zirconia powder (zirconium oxide) that has been processed through molding and sintering into three different shapes.
- a) Disc shape having groove around periphery.
- b) Disc shape without groove
- c) Rectangular solid
Using commercially available CAD/CAM systems, these blanks are then further fabricated into various prosthetic dental devices, such as crowns and bridges. The dental restoration is then fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved. All prosthetic dental devices are intended for single use applications.
ADAMANT ZIRCONIA DISC is supplied in different colors originating from the different constituent of color additives; and different translucencies originate from small differences in the amount of Y2 O3. Finally, the restorations may be color shaded following the CAD/CAM process.
The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.
Technological Characteristics Summary:
ADAMANT ZIRCONIA DISC is an oxide-based ceramic devices composed of partially sintered yttria stabilized zirconia powder indicated for dental restorations, such as crowns and bridges. The components of the ADAMANT ZIRCONIA DISC have been used in previously marketed devices and have been found safe for dental use. The data provided support the substantial equivalence of the subject device to the predicate devices for the indicated uses.
Technological Comparison with the Predicate Devices:
The following table shows similarities and differences of use, design, and material between the subject device and the predicate devices. The predicates were chosen based upon their material composition, indications for use, and physical characteristics.
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510(k) Premarket Notification
ADAMANT ZIRCONIA DISC
| Attribute | Subject Device | Predicate Devices | Predicate Devices | Comments |
|---|---|---|---|---|
| Trade Name | Adamant ZIRCONIA DISC | CERCON BASE | Dental Direkt cubeX2 | N/A |
| 510(k) Number | K160203 | K051462 | K150196 | N/A |
| DeviceDescription | The ADAMANT ZIRCONIADISC is a ceramic block,composed of partially sinteredyttria (yttrium oxide) stabilizedzirconia (zirconium oxide) (Y-TZP) that can be cut/milled forforming dental restorations suchas crowns and bridges (up to amaximum of three elements).Applications include both anteriorand posterior regions. TheADAMANT ZIRCONIA DISC isdesigned for milled production oncommercial CAD/CAM systems.After milling the disc, it is finalsintered, so the Zirconia Disc is | CERCON® BASE is a denseceramic composed of partiallysintered yttria (yttrium oxide)stabilized zirconia (zirconiumoxide) powder (Y-TZP). It isprocessed in the dental laboratoryby machining from a partiallysintered Y-TZP blank which isthen sintered to near full densityand then finally veneered with adental veneering ceramic. It isdesigned for anterior and posteriorlocations as a substructure(framework) for single tooth orbridge type restorations.CERCON® BASE is essentially | DD cubeX2 is a semi-finished dental blank madeof yttrium stabilized pre-sintered zirconium dioxide,which has a super hightranslucency. The ceramicsis of type II (not powder),Class 5 according to DINEN ISO 6872 (FDARecognition Number 4-178). The DD cubeX2dental blanks are designedfor milled production ofcrowns and bridgeframeworks on commercialCAD/CAM systems or | Same, with the exception thatthe Adamant Zirconia Disc isclassified as Class 1, 2 and 3(according to ISO 6872). |
| transformed into the object asdental restorations. | equivalent to other Y-TZPproducts currently in the market. | hand-operated copy millingmachines. | ||
| Regulatory Class | Class II | Class II | Class II | Same |
| Intended Use | Dental ceramic restorations madefrom ADAMANT ZIRCONIADISC are indicated for crowns andmulti-unit bridges (up to amaximum of three elements).Applications include both anteriorand posterior regions. | CERCON® BASE is indicatedfor crowns, multi-unit bridges,and inlay bridges. Applicationsinclude both anterior and posteriorregions. | Dental blanks made fromDD cubeX2 are indicatedfor crowns, multi-unitbridges (up to a maximumof three elements) and inlaybridges. Applicationsinclude both, anterior andposterior bridges. | Same, with the exception thatthe subject device is notintended for inlay bridges. |
| Multi-unitbridges | Up to a maximum of threeelements. | Multi-unit bridges (with no morethan two pontics betweenabutment crowns) | Up to a maximum of threeelements. | Same as K150196 |
| Chemical Composition [Units] | ||||
| ZrO2 + HfO2 +Y2O3 [wt%] | ≥ 99.0 | ≥ 99.0 | ≥ 99.0 | Same |
| HfO2[wt%] | ≤ 5 | ≤ 2 | ca. 0.2 | Minor differences in |
| Y2O3 [wt%] | ≤ 10 | ≤ 5 | < 10 | additives result in the |
| Al2O3 [wt%] | ≤ 5 | ≤ 1 | < 0.1 | availability of different |
| Other oxides | ≤ 5 | ≤ 1 | < 0.05 | colors and translucencies. |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| ISO 6872Categorization | Type II, Class 1, 2 and 3 (as theproduct is not intended forsubstructure) | Type II, Class 6 | Type II, Class 5 due torestrictionto 3-element restorations | Same Type, but differentClass, as the AdamantZirconia Disc is not intendedfor substructure, although itstechnological characteristicswould support such use.Therefore, substantialequivalence is not affected.Depending upon the colorvariant of the AdamantZirconia Disc, the flexuralstrength ranges from 515MPa to 1349 MPa. The low-end range of flexural strengthis mitigated by limitations setforth in labeling as per ISO6872. |
| Bending/FlexuralStrength [MPa] | 515 MPa – 1349 MPa | 1200 MPa | >720 MPa | |
| Density(after sintering)[g/cm3] | 6.04 ~ 6.33 g/cm³ | Unknown | > 6.0 | Same |
| Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 | Same |
| Physical Testing | ISO 6872 | ISO 6872 | ISO 6872 | Same |
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Performance Data (Non-Clinical):
Non-clinical testing was performed as follows.
| Biocompatibility Test Performed | Result |
|---|---|
| Cytotoxicity test: Colony formation cytotoxicity test | Passed.No cytotoxic effect. |
| Intracutaneous reactivity in rabbits | Passed.Met test requirements. |
| Skin Sensitization Study in the Guinea Pig(Maximization Method) | Passed.No skin sensitizationproduced. |
| Genotoxicity: Bacterial Reverse Mutation Study | Passed.Test article extractsnonmutagenic. |
| Test results according to Requirements of ISO 6872 | Result |
| Uniformity of the material | Passed |
| Freedom from extraneous materials | Passed |
| Physical and chemical properties: Activityconcentration of uranium 238 | Passed |
| Physical and chemical properties: Thermal expansioncoefficient | Passed |
| Physical and chemical properties: Flexural Strength | Passed |
| Physical and chemical properties: Chemical solubility | Passed |
Applicable Standards:
- · ISO 10993-1, 10993-5, 10993-10, Biological evaluation of medical devices
- · ISO 6872:2008, Dentistry Ceramic materials
Substantial Equivalence Conclusion:
Both the subject and predicate devices are oxide-based ceramic devices composed of partially sintered yttria stabilized zirconia powder indicated for dental restorations, such as crowns and bridges. Both the subject and predicate devices have similar chemical compositions and physical characteristics. Data, including bench and biocompatibility test results, is provided to assess the effects of any technological differences between the subject device and the predicate. These data demonstrate that the device performs as intended and support a finding of substantial equivalence.
§ 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.