(33 days)
Not Found
No
The device description and intended use focus on the material properties and fabrication method of zirconia blanks for dental restorations. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies are limited to material property testing.
No.
Explanation: The device is a material (zirconia blanks) used for fabricating dental restorations, not a therapeutic device itself. Its function is to be milled into dental prosthetics.
No
This device is a material (zirconia blanks) used for fabricating dental restorations, not for diagnosing medical conditions.
No
The device description clearly states it is made from "pre-sintered zirconia powder" and is a physical blank used in milling machines, indicating it is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fabricate dental restorations (substructures, restorations, crown frameworks, bridge frameworks). This is a manufacturing process for a medical device that will be used in the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a material (zirconia blanks) used in a manufacturing process (CAD/CAM or manual milling). It's not a reagent, instrument, or system designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnosing diseases, or providing information about a patient's health status based on in vitro testing.
Therefore, the Vericore zirconia blanks are a dental material used in the fabrication of dental prosthetics, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with many CAD/CAM or manual milling machines. Vericore zirconia blanks are biocompatible and designed to fabricate;
- Zirconia Substructures .
- -Restorations (Including inlays, onlays, and veneers)
- . Crown Framework in the Anterior and Posterior regions
- . Bridge Framework in the Anterior and Posterior regions
Prescription Use (21 CFR 801 Subpart D)
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Vericore Zirconia Blanks is a device made from pre-sintered zirconia powder. It is available in various shades, shapes, and sizes to accommodate the customers CAD/CAM or manual milling equipment/strategies and is not machine specific. Vericore Zirconia Blanks are made from a biocompatible zirconia powder. It is intended to be used by professionals for the fabrication of dental restorations.
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
professionals
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)
Flexural strength and chemical solubility tests were performed in accordance with ISO 6872 and all tests passed. Non-clinical testing for density was performed as well and the results are recorded in the proposed labeling.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three faces overlapping to suggest community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 22, 2014
Whip Mix Corporation Mr. John P. Waters Regulatory Compliance Officer 361 Farmington Avenue Louisville, KY 40217
Re: K142670
Trade/Device Name: Vericore Zirconia Blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: September 18, 2014 Received: September 25, 2014
Dear Mr. Waters:
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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Page 2 - Mr. Waters
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.
Susan Runno DDS, MA
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):____K142670
Indications for Use:
Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with many CAD/CAM or manual milling machines. Vericore zirconia blanks are biocompatible and designed to fabricate;
- Zirconia Substructures .
- -Restorations (Including inlays, onlays, and veneers)
- . Crown Framework in the Anterior and Posterior regions
- . Bridge Framework in the Anterior and Posterior regions
Prescription Use (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CRR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of
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(Special) 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92
Date Prepared: 9/18/2014
1. APPLICANT
Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217
PHONE: 502-634-5357 FAX: 502-634-4512 EMAIL: jwaters@whipmix.com
2. SUBMITTER and CONTACT
John P. Waters Regulatory Compliance Officer & Official Correspondent for Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217
PHONE: 502-634-5357 FAX: 502-634-4512 EMAIL: DATE: DATE: 9/18/2014
3. DEVICE NAME
Vericore Zirconia Blanks
4. COMMON OR USUAL NAME AND CLASSIFICATION
Powder, Porcelain Regulation Number: 872.6660 Product Code: EIH Classification: Class II
5. PREDICATE DEVICE INFORMATION
Whip Mix Vericore Zironia Blanks (K140877)
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6. DEVICE DESCRIPTION
Vericore Zirconia Blanks is a device made from pre-sintered zirconia powder. It is available in various shades, shapes, and sizes to accommodate the customers CAD/CAM or manual milling equipment/strategies and is not machine specific. Vericore Zirconia Blanks are made from a biocompatible zirconia powder. It is intended to be used by professionals for the fabrication of dental restorations.
7. INTENDED USE
Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with many CAD/CAM or manual milling machines. Vericore zirconia blanks are biocompatible and designed to fabricate;
- -Zirconia Substructures
- Restorations (Including inlays, onlays, and veneers) -
- Crown Framework in the Anterior and Posterior regions -
- -Bridge Framework in the Anterior and Posterior regions
8. SUBSTANTIAL EQUIVALENCE WITH PREDICATE DEVICES
| Whip Mix Corporation | Whip Mix Corporation |
|---|---|
| Proposed new device | Predicate Device |
| Vericore Zirconia Blanks | Vericore Zirconia Blanks |
| Class II Device | Class II Device |
| 510(k) Pending | 510(k) K140877 |
| Product Code EIH | Product Code EIH |
| Regulation Number- 872.6660 | Regulation Number- 872.6660 |
| Material- Biocompatible zirconia powder | Material- Biocompatible zirconia powder |
| manufactured by Tosoh Corporation | manufactured by Tosoh Corporation |
| Indications For Use | Indications For Use |
| Vericore zirconia blanks are made from pre- | Vericore zirconia blanks are made from pre- |
| sintered zirconium dioxide intended to be used | sintered zirconium dioxide intended to be |
| with many CAD/CAM or manual milling machines. | used with many CAD/CAM or manual milling |
| Vericore zirconia blanks are biocompatible and | machines. Vericore zirconia blanks are |
| designed to fabricate; | biocompatible and designed to fabricate; |
| - Zirconia Substructures | - Zirconia Substructures |
| - Restorations (Including inlays, onlays, and | - Restorations (Including inlays, onlays, |
| veneers) | and veneers) |
| - Crown Framework in the Anterior and | - Crown Framework in the Anterior and |
| Posterior regions | Posterior regions |
| - Bridge Framework in the Anterior and | - Bridge Framework in the Anterior and |
| Posterior regions | Posterior regions |
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9. BENCH TESTING
Flexural strength and chemical solubility tests were performed in accordance with ISO 6872 and all tests passed. Non-clinical testing for density was performed as well and the results are recorded in the proposed labeling.
10. BIOCOMPATIBILITY
The product is biocompatible because the predicate device was tested in accordance with ISO 10993-10, 10993-3, and 10993-5. No further biocompatibility tests are necessary because Whip Mix Vericore Blanks are made from the same powder as the predicate.
11. SAFETY AND EFFECTIVENESS CONCLUSION
This additional of the Ultra-Translucent Vericore® Zirconia Blanks are substantially equivalent to Whip Mix Vericore Zirconia Blanks material in safety and effectiveness when used in accordance with the instructions for use. Both have identical Indications for Use, use the same raw material, and are biocompatible.