Heany Industries, Inc. "Luxisse +" is non-implantable Zirconia material intended for CAD/CAM fabrication of all ceramic dental restorations. The material is used for the manufacturing of inlays, veneers, single unit anterior and posterior crowns, and three unit anterior bridges.

Device Description

Heany Industries Inc. "Luxisse +" is an all ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a block or disk shape. CAD/CAM fabrication of core material can then be used to produce copings and substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, single unit posterior and anterior crowns, and three unit anterior bridges. The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer.

AI/ML Overview

The provided text describes the "Luxisse +" device, a Zirconia material for CAD/CAM fabrication of all-ceramic dental restorations. The document is a 510(k) summary for premarket notification to the FDA, asserting substantial equivalence to a predicate device, "Heany Industries, Inc. Dental Zirconia" (K073314).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are derived from the consensus design standard ISO 6872:2008, "Dentistry - Ceramic Materials", and BS EN 1641:2004, "Dentistry, Medical Devices for Dentistry, Materials." The reported device performance is presented in "Table 2: Testing performed for the 'Luxisse + ' 510(k) Submission" and implicitly through the device comparison chart (Table 1) where specific values are listed.

Test / Acceptance Criteria (Standard Reference: ISO 6872:2008 (E))	Reported Device Performance ("Luxisse +")	Comparison to Predicate (Dental Zirconia, where applicable)
Radioactivity Concentration	Met predefined criteria as specified in ISO 6872:2008 (E).	Not explicitly stated for predicate in summary.
Flexural Strength	Met requirements as specified in ISO 6872:2008 (E). (Specific value: 546 MPa)	Predicate: 1200 MPa ± 150 MPa
Uniformity	Met predefined criteria as specified in ISO 6872:2008 (E).	Not explicitly stated for predicate in summary.
Coefficient of Thermal Expansion (CTE)	Met predefined criteria as specified in ISO 6872:2008 (E). (Specific value: $10 \times 10^{-6}/K$)	Predicate: $10 \times 10^{-6}/K$
Fracture Toughness (KIC)	Met predefined criteria as specified in ISO 6872:2008 (E). (Specific value: 5.83 MPam^0.5)	Predicate: 8 MPam^0.5
Chemical Solubility in Water	Met predefined criteria as specified in ISO 6872:2008 (E). (Specific value: < 10 µg/cm$^2$)	Predicate: <14 µg/cm$^2$
Bulk Density (sintered)	6.05 g/cm$^3$	Predicate: 6.05 g/cm$^3$
Porosity	< 0.5 %	Predicate: < 0.5 %
Sintering Temperature	1450 °C	Predicate: 1450 °C
Translucency (Transmittance)	41%	Predicate: 49%

Note: While "Luxisse +" met the requirements for flexural strength and fracture toughness as per ISO 6872:2008, its specific values are lower than those reported for the predicate device. The filing argues substantial equivalence based on meeting the standard rather than directly matching predicate values in these cases, stating "The formulations have not been changed in ways that may adversely impact device performance."

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 explicitly state the sample size used for the non-clinical tests (e.g., number of specimens tested for flexural strength). It also does not mention the country of origin of the data or whether the tests were retrospective or prospective. It only states that "Non-clinical testing was performed in order to validate the design against the Company's specified design requirements... and to assure conformance with the consensus design standard ISO 6872:2008."

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 information is not applicable as the described studies are non-clinical (material property testing) and do not involve human subject data or expert review for ground truth establishment. The ground truth is the predefined criteria/requirements of the ISO 6872:2008 standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable as the studies are non-clinical material property tests, not human subject studies requiring adjudication.

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 information is not applicable. The device is a dental material, not an AI-powered diagnostic or assistive tool for human readers. There was no clinical testing performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable. The device is a dental material, not an algorithm. However, the non-clinical performance data can be considered a "standalone" evaluation of the material's properties against established standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the non-clinical performance evaluation is the predefined criteria and specifications outlined in the consensus design standards, specifically ISO 6872:2008 and BS EN 1641:2004. The testing assessed whether the material properties of "Luxisse +" conformed to these established standards for dental ceramic materials.

8. The sample size for the training set:

This information is not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

9. How the ground truth for the training set was established:

This information is not applicable for the same reason as #8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 6, 2015

Heany Industries. Inc. c/o Carrie Hetrick, DDS Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701

Re: K150056

Trade/Device Name: Luxisse + Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH Dated: February 6, 2015 Received: February 9, 2015

Dear Dr. Hetrick:

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.

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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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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. Tina Kiana -S

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

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Indications for Use

510(k) Number (if known)

Device Name "Luxisse +"

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

for

"Luxisse +"

1. Submission Sponsor

Heany Industries, Inc. 249 Briarwood Lane Scottsville, NY 14546 United States of America Phone: (585) 889-2700 Fax: (585) 889-2708 Contact: Cliff Rabidoux, Senior VP

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (720) 838.4113 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant, RA Email: project.management@emergogroup.com

3. Date Prepared

5/4/2015

4. Device Identification

Trade/Proprietary Name:	"Luxisse +"
Common/Usual Name:	Porcelain powder for clinical use
Classification Name:	Powder, Porcelain
Classification Regulation:	21 CFR § 872.6660
Product Code:	EIH
Device Class:	Class II
Classification Panel:	Dental

5. Legally Marketed Predicate Device(s)

Heany Industries, Inc. Dental Zirconia 510(k) Number K073314 (Predicate) VITA Zahnfabrik H. Rauter GmbH & Co. Vita Suprinity 510(k) Number K132070 (Reference)

6. Device Description

Heany Industries Inc. "Luxisse +" is an all ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a block or disk shape. CAD/CAM

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fabrication of core material can then be used to produce copings and substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, single unit posterior and anterior crowns, and three unit anterior bridges. The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer.

7. Indication for Use Statement

Heany Industries, Inc. "Luxisse +" is non-implantable Zirconia material intended for CAD/CAM fabrication of all ceramic dental restorations. The material is used for the manufacturing of inlays, onlays, veneers, single unit anterior and posterior crowns, and three unit anterior bridges.

8. Substantial Equivalence Discussion

The following table compares the "Luxisse +" to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Manufacturer	Heany Industries, Inc.	Heany Industries, Inc(Predicate)
Trade Name	"Luxisse +"	Dental Zirconia
510(k) Number	K150056	K073314
Product Code	EIH	EIH
Regulation Number	21 CFR § 872.6660	21 CFR § 872.6660
Regulation Name	Porcelain Powder for Clinical Use	Porcelain Powder for Clinical Use
Indications for Use	Heany Industries, Inc. "Luxisse +" isnon-implantable, machinable Zirconiamaterial intended for CAD/CAMfabrication of all ceramic dentalrestorations. The material is used forthe manufacturing of inlays, onlays,veneers, single unit anterior andposterior crowns, and 3 unit anteriorbridges.	Heany Industries Inc. Dental Zirconia isnon-implantable material intended forCAD/CAM fabrication of core materialused in all-ceramic dental restorations.The material is used for themanufacturing of inlays, onlays,veneers, crowns and bridges
Material (wt%)	Zirconia99.8 wt% [ZrO2 + Y2O3 + HfO2 + Al2O3]	Zirconia99.55-99.7 wt% [ZrO2 + Y2O3 + HfO2 +Al2O3]
Shapes	Blocks, disks	Blocks, disks
Dimensions	Various	Various
Supplied Sterile	No	No
Single Use	Yes	Yes
Bulk density, g/cm³(sintered)	6.05 g/cm³	6.05 g/cm³
Porosity	< 0.5 %	< 0.5 %
Flexural Strength,MPa (sintered)	546 MPa	1200 MPa ± 150 MPa
Fracture Toughness	5.83 MPam0.5	8 MPam0.5

Table 1: Device Comparison Chart

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Manufacturer	Heany Industries, Inc.	Heany Industries, Inc(Predicate)
Trade Name	"Luxisse +"	Dental Zirconia
Thermal Expansion:	$10 x 10^{-6}/K$	$10 x 10^{-6}/K$
ThermalConductivity:	2.5 W/mK	2.5 W/mK
Chemical Solubilityin Water:	< 10 µg/cm2	-14 µg/cm2
SinteringTemperature (°C)	1450 °C	1450 °C
Translucency	41% Transmittance	49% Transmittance

The "Luxisse +" device shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate device. All of the components have been used in legally marketed devices. The formulations have not been changed in ways that may adversely impact device performance.

9. Non-Clinical Performance Data

Non-clinical testing was performed in order to validate the design against the Company's specified design requirements for physical and chemical properties, as well as flexural strength, and to assure conformance with the consensus design standard ISO 6872:2008. "Luxisse +" is classified as Type II Class 1a and b, 2a, and 4b esthetic dental ceramic.

The disks and blocks can be fabricated into various prosthetic dental devices and the zirconia powder conforms to ISO 6872:2008, Dentistry - Ceramic Materials and BS EN 1641:2004, Dentistry, Medical Devices for Dentistry, Materials. The table below summarizes the results.

Test	Conclusion
RadioactivityConcentration	The results meeting the predefined criteria as specified in ISO 6872: 2008 (E) supports a finding of substantial equivalence
Flexural Strength	The results met the requirements as specified in ISO 6872: 2008(E). Weibull statistics were used to better describe the distribution of strength. Ceramic materials exhibit unusually wide scatter in measured strength values due to a distribution of strength limiting defects. High variation in strengths cannot be accounted for solely by experimental error.
Uniformity	The results meeting the predefined criteria as specified in ISO 6872: 2008 (E) supports a finding of substantial equivalence.
Coefficient of thermalexpansion (CTE)	The CTE results meeting the predefined criteria as specified in ISO 6872: 2008 (E) supports a finding of substantial equivalence.
Fracture Toughness(KIC)	The results meeting the predefined criteria as specified in ISO 6872: 2008 (E) supports a finding of substantial equivalence.
Chemical Solubility	The results meeting the predefined criteria as specified in ISO 6872: 2008 (E) supports a finding of substantial equivalence.

Table 2: Testing performed for the "Luxisse +" 510(k) Submission

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The "Luxisse +" meets all the requirements for overall design and biocompatibility, and performance testing confirms that the output meets the design inputs and specifications. The "Luxisse +" passed all testing stated above as shown by the acceptable results obtained.

The "Luxisse +" complies with the applicable voluntary standards for performance. The device passed all the testing in accordance with national and international standards.

10. Clinical Performance Data

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years and there are no adverse reactions. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device.

The "Luxisse +" has the same or similar intended use, indications, principles of operation, and technological characteristics as the predicate devices. "Luxisse +", as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices in terms of intended use, design, materials, and function.

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.