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

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.

AI/ML Overview

The provided text is a FDA 510(k) premarket notification for a dental device, "Vericore Zirconia Blanks". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of a device's performance against specific acceptance criteria in a clinical setting. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment for a clinical study is not available in the provided text.

However, I can extract information related to the bench testing conducted.

Here's a breakdown of the available information:

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

Test	Acceptance Criteria	Reported Device Performance
Flexural Strength	In accordance with ISO 6872	"all tests passed"
Chemical Solubility	In accordance with ISO 6872	"all tests passed"
Density	(Not specified, but results were recorded)	"results are recorded in the proposed labeling"

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for the bench tests.
Data Provenance: Not specified, but generally, bench testing data for medical devices would originate from the manufacturer's testing facilities (likely in the USA, given the applicant's address). The tests are prospective in nature as they are conducted for this specific submission.

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)

Not applicable. Bench testing does not typically involve human experts for establishing ground truth as it measures material properties based on established standards.

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

Not applicable. Bench testing does not involve 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

No, an MRMC comparative effectiveness study was not done. This document is for a physical dental material, not an AI-powered diagnostic device.

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

No, a standalone performance study was not done. This document is for a physical dental material, not an algorithm.

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

For the bench tests (Flexural Strength, Chemical Solubility, Density), the "ground truth" is based on established international standards (ISO 6872) for material properties.

8. The sample size for the training set

Not applicable. This is a physical dental material, not a machine learning algorithm, so there is no "training set."

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

Not applicable. There is no training set for a physical dental material.

In summary, the provided document details the regulatory submission for a dental material (Vericore Zirconia Blanks). The "study" described refers to bench testing to ensure the material meets specified physical and chemical properties according to international standards (ISO 6872). It does not involve a clinical study with human subjects, expert readers, or AI performance metrics.

Summary

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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:

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)

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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

7. INTENDED USE

-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.

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.