(114 days)
No
The summary describes a dental material (zirconia) used for CAD/CAM fabrication, with no mention of software, algorithms, or any AI/ML related terms.
No
This device is a material (Zirconia) used for CAD/CAM fabrication of dental restorations like inlays, veneers, and crowns. It is a component used in creating prosthetic devices, not a therapeutic device itself.
No
This device is a material (Zirconia) used for fabricating dental restorations (inlays, veneers, crowns, bridges), not for diagnosing conditions.
No
The device is described as a physical material (Zirconia) provided in block or disk shape for CAD/CAM fabrication, which is then fired in an oven. This clearly indicates a hardware component, not a software-only 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 fabrication of dental restorations (inlays, veneers, crowns, bridges). This is a structural material used in the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a ceramic material (Zirconia) used for creating dental prosthetics. It's a physical material that is milled and fired.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a material used to create a physical restoration for dental purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
EIH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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. Testing included Radioactivity Concentration, Flexural Strength, Uniformity, Coefficient of thermal expansion (CTE), Fracture Toughness (KIC), and Chemical Solubility. All results met predefined criteria as specified in ISO 6872: 2008(E) and supported a finding of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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)
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.
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)
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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
4
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 +" is
non-implantable, machinable 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 3 unit anterior
bridges. | Heany Industries Inc. Dental Zirconia is
non-implantable material intended for
CAD/CAM fabrication of core material
used in all-ceramic dental restorations.
The material is used for the
manufacturing of inlays, onlays,
veneers, crowns and bridges |
| Material (wt%) | Zirconia
99.8 wt% [ZrO2 + Y2O3 + HfO2 + Al2O3] | Zirconia
99.55-99.7 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 |