KDF Zirconia Disc is indicated for the production of dental ceramic restorations, specifically inlays, onlays, veneers, artificial teeth, crowns and bridges, which is manufactured by CAD / CAM processing. The application includes both anterior teeth and posterior teeth areas. All blocks are processed by a dental laboratory or dental technician.

Device Description

KDF Zirconia Disc is used for custom made dental restorations using a CAD/CAM system by dental professionals. The subjected device has disc shapes and various shades and thicknesses as follow.
KDF Zirconia Disc is mainly composed of zirconium oxide (ZrO2) and contain other oxides as stabilizers or/and colorants. The device is two different classifications according to ISO 6872: 2015 depending on shades. MU series are classified as type II class 4 ceramic, otherwise are classified as type II class 5 ceramic.

AI/ML Overview

I am sorry, but I cannot answer your request for specific details regarding the Acceptance Criteria and Study that proves the device meets the Acceptance Criteria using the provided text. The document provided outlines a 510(k) premarket notification for a dental ceramic restoration device (KDF Zirconia Disc) and includes non-clinical performance testing results against recognized standards (ISO 6872:2015 and ISO 10993 series). While it presents acceptance criteria and reported device performance in a table, it does not contain the following information you requested:

Sample sized used for the test set and the data provenance: The document states that "all samples" and "all fully sintered test articles" were tested, but does not provide a specific number. The origin of the data (country, retrospective/prospective) is not mentioned.
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 type of information is generally related to clinical studies or expert review for diagnostic devices, which is not applicable to this material device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Again, this relates more to diagnostic device performance evaluation with expert review, which is not the context here.
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 type of study is for AI-assisted diagnostic devices and is not relevant to a dental material device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is also for AI/algorithm-based devices.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is defined by the technical specifications and criteria set forth in the ISO standards, not expert consensus or pathology data in the typical sense for diagnostic applications.
The sample size for the training set: The document does not describe any training set as it pertains to AI or machine learning. The "training" in this context would implicitly be the process of developing and manufacturing the zirconia disc to meet the ISO standards.
How the ground truth for the training set was established: As there is no "training set" in the context of an AI/machine learning device, this information is not provided.

The provided text focuses on the physical and chemical properties of the KDF Zirconia Disc, demonstrating its compliance with international standards for dental ceramic materials and biocompatibility for establishing substantial equivalence to predicate devices. It does not involve AI, diagnostic performance, or human reader studies.

Here is the table of acceptance criteria and reported device performance from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria	Results	Judgment
Uniformity and Freedom from extraneous materials	No pigment unbalance and foreign materials shall be found on any of the top, bottom, or side surfaces of the disc when visual inspection is made.	No pigment unbalance and foreign material was identified.	Passed.
Activity Concentration	<1.0 Bq/g of 238U	The radioactivity concentration (238U) of all samples was less than 1.0 Bq/g.	Passed.
Flexural Strength	MT series: ≥800 MPa MU series: ≥500 MPa	The flexural strength of MT series with fully sintering were all greater than 800 MPa; similarly for MU series, all test articles showed greater than 500 MPa.	Passed.
Chemical Solubility	< 100 µg/cm2	The chemical solubilities of all fully sintered test articles were all less than 100 µg/cm2.	Passed.
Coefficient of Thermal Expansion	(10.7±0.5) ×10-6 K-1	The coefficients of thermal expansion for all fully sintered test articles were all within the range of (10.7±0.5) ×10-6 K-1.	Passed.
Shrinkage Factor	MT series: 1.217~~1.226±0.002 MU series: 1.225~~1.235±0.002	The shrinkage factor of MT and MU with fully sintering showed 1.217~~1.226±0.002 and 1.225~~1.235±0.002, respectively.	Passed.

Regarding the other requested information:

Sample sized used for the test set and the data provenance: Not explicitly stated. The document refers to "all samples" and "all fully sintered test articles." Data provenance (country of origin, retrospective/prospective) is not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to this type of device (dental material). Ground truth is established by ISO standards.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not applicable to a material device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not applicable to a material device.
The type of ground truth used: The ground truth for performance is based on the specifications and requirements defined in recognized international standards, specifically ISO 6872:2015 for dental ceramic materials and ISO 10993 series for biocompatibility.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

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July 14, 2022

DENKEN-HIGHDENTAL Co., Ltd. Noriko Tanji 24-3 Kisshoin Ishiharakyomichi-cho Minami-ku, Kyoto 601-8356 JAPAN

Re: K221429

Trade/Device Name: KDF Zirconia Disc Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 10, 2022 Received: May 16, 2022

Dear Noriko Tanji:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael E. Adjodha Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K221429

Device Name KDF Zirconia Disc

Indications for Use (Describe)

K.DF Zirconia Disc is indicated for the production of dental ceramic restorations, specifically inlays, veneers, artificial teeth, crowns and bridges, which is manufactured by CAD / CAM processing, The application includes both anterior teeth and posterior teeth areas. All blocks are processed by a dental laboratory or dental technician.

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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K221429

Traditional 510(k) Premarket Notification: KDF Zirconia Disc

5. 510(k) Summary

Date of Preparation: May 10, 2022

Applicant:

DENKEN-HIGHDENTAL Co., Ltd. 24-3 Kisshoin Ishiharakyomichi-cho, Minami-ku, Kyoto, 601-8356, Japan Contact Person: Daijiro Goto Manager of Overseas Sales Dept. Phone: +81 75-672-2124 Fax: +81 75-672-2125 e-mail: gotou-dai(@awi.co.jp

Contact:

Noriko Tanji Quality Assurance Group DENKEN-HIGHDENTAL Co., Ltd. 24-3 Kisshoin Ishiharakyomichi-cho, Minami-ku, Kyoto, 601-8356, Japan Phone: +81-75-672-2124 Fax:+81 75-672-2136 e-mail: tanji-nor@awi.co.jp

Manufacturer:

Manufactured by DENKEN-HIGHDENTAL Co., Ltd. Address; 24-3 Kisshoin Ishiharakyomichi-cho, Minami-ku, Kyoto, 601-8356, Japan

Name of Device(s):

Trade Name:	KDF Zirconia Disc
Common Name	Dental appliance fabrication materials, ceramic
Regulation Name(s):	Powder, Porcelain
Classification Name:	Porcelain powder for clinical use

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Regulation Number:	872.6660
Regulatory Class:	II
Product Code:	EIH
Panel:	Dental

Predicate Device

Primary Predicate Device:

LUXEN Zr, LUXEN Smile (K171585) by DENTALMAX Co., Ltd.

Secondary Predicate Device:

Dental Zirconia Blocks (K192262) by De Corematrix Co., Ltd.

Device Description

KDF Zirconia Disc is used for custom made dental restorations using a CAD/CAM system by dental professionals. The subjected device has disc shapes and various shades and thicknesses as follow.

Please refer to Appendix 7 for the list of model names and specifications for KDF Zirconia Disc.

Shade
Monochromatic shade	Pure
MT series	MT-BL1, MT-BL2, MT-BL3,MT-A1, MT-A2, MT-A3, MT-A3.5, MT-A4
MU series	MU-Pure, MU-BL1, MU-BL2, MU-BL3MU-A1、MU-A2、MU-A3、MU-A3.5、MU-A4、
Size
Diameter (mm)	φ 98.5
Thickness (mm)	10, 14, 16, 18, 20, 22, 25, 30, 35

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KDF Zirconia Disc is mainly composed of zirconium oxide (ZrO2) and contain other oxides as stabilizers or/and colorants. The device is two different classifications according to ISO 6872: 2015 depending on shades. MU series are classified as type II class 4 ceramic, otherwise are classified as type II class 5 ceramic.

Indications for Use

Comparison to Predicate Device
--------------------------------	--	--	--

	Proposed Device	Primary Predicate Device		Secondary Predicate Device	Comparison			Disk typeWieland typeD-95 type	Disk typeWieland typeD-95 type	Disc			-MU$\ge$ 500 MPa				by ISO 6872 for type IIclass 5 or class 4ceramics
Device Name	KDF Zirconia Disc	LUXEN Zr	LUXEN Smile	Dental Zirconia Blocks	N/A	Color	-MonochronicPure,-MT seriesMT-BL1, MT-BL2, MT-BL3,MT-A1, MT-A2, MT-A3,MT-A3.5, MT-A4-MU seriesMU-Pure, MU-BL1, MU-BL2,MU-BL3, MU-A1, MU-A2,MU-A3, MU-A3.5, MU-A4	A0, A1, A2, A3,A3.5, A4, B1, B2,B3, B4, C1, C2,C3, C4, D2, D3,D4	A0, A1, A2, A3,B1, B2, B3, B4,C4, A1-A2-B3-B4LAYER, B1-B2-B3-B4 LAYER	White and Colour	All products have adisc type.The shade provided onthe type and amountsof pigments contained.	ThermalExpansionCoefficient	10.7×10-6 K-1	10.7×10-6 K-1	10.3×10-6 K-1	Unknown	Same with LUXENZr.
Manufacturer	DENKEN-HIGHDENTAL Co., Ltd.	DENTALMAX Co., Ltd.	DENTALMAX Co., Ltd.	De Corematrix Co., Ltd.	N/A	SinteringTemperature	1500°C	LUXENST:1580°COthers:1500°C	Zr 1450°C	1400-1600°C	Similar	ChemicalSolubility	<100 µg/cm2	0 µg/cm2	0 µg/cm2	<100 µg/cm2	Chemical solubility ofall products conformsto ISO 6872 for typeII class 5 or class 4dental ceramics.
510(k) Number		K171585	K171585	K192262	N/A	Types,Class(ISO 6872:2015)	-Pure and MTType II Class 5-MUType II Class 4	Type II Class 5	Type II Class 4b	Type II Class 5	Pure and MT areclassified in the sametype as LUXEN Zrand Dental ZirconiaBlocks.MU is classified asclass 4 ceramics, someetstherequirements of Class4b, under whichLUXEN Smile isclassified.	Biocompatibility	ISO10993-1 andISO 7405	Device isbiocompatiblewhen used asdirected by dentalprofessionals perISO 10993-1.	Device isbiocompatiblewhen used asdirected by dentalprofessionals perISO 10993-1.	Comply with ISO10993-1:2018,FDAGuidance	All products arebiocompatible.
Classification Name	Porcelain powder for clinical use	Porcelain powder for clinical use	Porcelain powder for clinical use	Porcelain powder for clinical use	Same	ChemicalComposition	ZrO2+Y2O3+HfO2: >98Al2O3: <0.5SiO2: <0.05Other inorganicpigments: <1	Zirconia PowderZpexZrO2+HfO2+Y2O3:>99.8Other oxides(Al2O3, SiO2,Fe2O3): <0.2Zirconia PowderZpex YellowZrO2+HfO2+Y2O3:>99.8Other oxides(Al2O3, SiO2,Fe2O3): <0.2Zirconia PowderZpex PinkZrO2+HfO2+Er2O3 :≥99.8Other oxides(Al2O3, SiO2,Fe2O3): <0.2	Zirconia PowderZpex SmileZrO2+HfO2+Y2O3:>99.8Other oxides(Al2O3, SiO2,Fe2O3): <0.2Zirconia PowderZpex YellowZrO2+HfO2+Y2O3:>99.8Other oxides(Al2O3, SiO2,Fe2O3): <0.2Zirconia PowderZpex PinkZrO2+HfO2+Er2O3 :≥99.8Other oxides(Al2O3, SiO2,Fe2O3): <0.2	White zirconiaZrO2+HfO2+Y2O3: ≥99.0Al2O3: ≤0.5Other oxide: ≤0.5Colour ZirconiaZrO2+HfO2+Y2O3≥98.0Fe2O3: <0.3Pr2O3: <0.2Er2O3: <1Other oxide: ≤0.5	Similar.All products containZrO2, Y2O3 and HfO2as the maincomponent and smallamount of other oxide.Although there aredifferences in pigmentcomposition andcontent, they are verysmall amounts and donot affect performanceand safety.	Sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Same
Product Code	EIH	EIH	EIH	EIH	Same	Flexural Strength	-Pure and MT>800 MPa	1038±135 MPa	770 ±66 MPa	>800 MPa	Flexural strength ishigher than required
Device Class	Class II	Class II	Class II	Class II	Same
Indications for Use	KDF Zirconia Disc is indicated for the production of dental ceramic restorations, specifically inlays, onlays, veneers, artificial teeth, crowns and bridges, which is manufactured by CAD / CAM processing. The application includes both anterior teeth and posterior teeth areas. All blocks are processed by a dental laboratory or dental technician.	LUXEN Zr is indicated for the production of all ceramic inlays, multiunits bridges, onlays, and veneers without zirconium dioxide frameworks.	LUXEN Smile is indicated for the production of of full ceramic crowns, onlays, 3- bridges and inlay bridges (anterior and molar).	Dental Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers. All Blocks are processed through dental laboratories or by dental professionals.	SimilarAll products are indicated for dental restorations.
Shapes	Disc type	Block type	Block type	Blocks.	Same

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Performance (Non-Clinical) Testing

Non-clinical testing data are submitted to demonstrate substantial equivalence following FDA recognized standards:

·ISO 6872:2015, Dentistry Ceramic materials
•ISO 7405:2018, Dentistry Evaluation of biocompatibility of medical devices used in dentistry
•ISO 10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

The biocompatibility studies were performed in accordance with ISO 10993 series.

a) Performance Testing

Performance testing of the KDF Zirconia Disc was performed in accordance with ISO 6872:2015. As shown in the table below, all test results indicate that the devices conform to the requirements of the standard and falls under Type II Class 5 ceramic or Class4 ceramic as with the predicates.

Therefore, it was concluded that KDF Zirconia Disc has substantially equivalent physical properties and performance to the predicate devices.

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Test Performed	Acceptance Criteria	Results	Judgment
Uniformity andFreedom fromextraneousmaterials	No pigment unbalanceand foreign materialsshall be found on any ofthe top, bottom, or sidesurfaces of the disc whenvisual inspection ismade.	No pigment unbalance and foreignmaterial was identified.	Passed.
ActivityConcentration	<1.0 Bq/g of 238U	The radioactivity concentration(238U) of all samples was less than1.0 Bq/g.	Passed.
FlexuralStrength	MT series: ≥800 MPaMU series: ≥500 MPa	The flexural strength of MT serieswith fully sintering were all greaterthan 800 MPa; similarly for MUseries, all test articles showedgreater than 500 MPa.	Passed.
ChemicalSolubility	< 100 µg/cm2	The chemical solubilities of allfully sintered test articles were allless than 100 µg/cm2.	Passed.
Coefficient ofThermalExpansion	(10.7±0.5) ×10-6 K-1	The coefficients of thermalexpansion for all fully sintered testarticles were all within the range of(10.7±0.5) ×10-6 K-1.	Passed.
Shrinkage Factor	MT series:1.217~~1.226±0.002MU series:1.225~~1.235±0.002	Passed.The shrinkage factor of MT andMU with fully sintering showed1.217~~1.226±0.002 and1.225~~1.235±0.002, respectively.	Passed.

b) Biocompatibility

The biocompatibility risk assessment of KDF Zirconia Disc was performed according to ISO 10993-1:2018 and ISO 7405:2018. The tests conducted in accordance with the ISO 10993 series described above showed no significant adverse effects under the conditions of the studies. Based on the results of these studies, the risk of the biocompatibility-related hazards from the use of the device is extremely low, and all biocompatibility risks of the device are determined acceptable.

Therefore, the KDF Zirconia Disc conforms to ISO 10993-1:2018 and ISO

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7405:2018, indicating that the safety of the device is substantially equivalent to the predicates.

Conclusion

The conclusions drawn from the comparison and analysis above demonstrate that the differences between the proposed device and the predicated device are insignificant in terms of substantial equivalence. The proposed device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.