(87 days)
Not Found
No
The summary describes a material (dental zirconia) used in CAD/CAM fabrication, not a software or system that would typically incorporate AI/ML. There are no mentions of AI, ML, or related concepts in the text.
No
The device is a material (zirconium oxide) used for manufacturing dental restorations like inlays, veneers, crowns, and bridges, which are structural components rather than active agents that treat or prevent disease.
No
The device description indicates it is a material used for the CAD/CAM fabrication of dental restorations (inlays, veneers, crowns, bridges), which is a treatment or restorative function, not a diagnostic one.
No
The device description clearly states it is a physical material (zirconium oxide block or disk) used for CAD/CAM fabrication, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device description: The description clearly states that Heany Industries Inc. Dental Zirconia is a material used for fabricating dental restorations (inlays, veneers, crowns, bridges). It is a physical material that is milled and fired to create a dental component.
- Intended Use: The intended use is for the CAD/CAM fabrication of core material for dental restorations, which are placed in the mouth, not used to test samples from the body.
Therefore, this device falls under the category of a dental material or prosthetic component, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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, veneers, crowns and bridges.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Heany Industries Inc. Dental Zirconia is an all ceramic core material made of zirconium oxide. It is provided as a block or cisk shape. CAD/CAM fabrication of core matcrial can then be used to produce copings and or substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, crowns and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility, physical and mechanical properties have been tested to show Heany Industries Inc. Dental Zirconia is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
V. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter
FEB 21 2008
| Name: | Heany Industries Inc |
|---|---|
| Street: | 249 Briarwood Lane |
| City: | Scottsville |
| State: | NY |
| Zip-Code: | 14546 |
| Country: | USA |
| Contact: | Corey Dunn |
| Ceramic Engineer | |
| Phone: | 585-889-2700 |
| Fax: | 585-889-2708 |
| E-mail: | coreyd@heany.com |
| Date: | 11/16/07 |
Name of Device
| Proprietary Name: | Heany Industries Inc. Dental Zirconia |
|---|---|
| Classification Name: | Porcelain powder for clinical use |
| Common Name: | All-ceramic core material |
Predicate Devices
Foundation Milling Center Z-Blocks .......K06 389 (Foundation Milling Center (FMC)
LAVA™ Frame:...............................................K011394 (3M ESPE AG)
IPS E.MAX CAD/IPS E.MAX ZIRCAD ... K051705 (Ivoclar Vivadent, Inc.)
Description for the Premarket Notification
Heany Industries Inc. Dental Zirconia is an all ceramic core material made of zirconium oxide. It is provided as a block or cisk shape. CAD/CAM fabrication of core matcrial can then be used to produce copings and or substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, crowns and bridges. The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer.
The technological characteristics between the predicate and proposed devices are identical. All chemical ingredients for the proposed device are already contained in the predicate devices. Biocompatibility, physical and mechanical properties have been tested to show Heany Industries Inc. Dental Zirconia is as safe and effective as the predicate devices.
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Image /page/1/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" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus or a staff with a serpent entwined around it.
FEB 21 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Corey Dunn Ceramic Engineer Heany Industries Incorporated 249 Briarwood Lane Scottsville, New York 14546
Re: K073314
Trade/Device Name: Heany Industries Incorporated Dental Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 20, 2007 Received: November 26, 2007
Dear Mr. Dunn:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Dunn
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Elsie Rivera-Velez
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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 : K073314
Device Name: __ Heany Industries Inc. Dental Zirconia
Indications for Use:
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, veneers, crowns and bridges.
Prescription Use X (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Syson funner (Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
:
510(k) Number: x x o 7 33 /4
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