(149 days)
Not Found
No
The device description and intended use focus on the material properties and fabrication method (CAD/CAM or manual milling) of zirconia blanks, with no mention of AI or ML.
No
The device is a material (zirconia blanks) used for fabricating dental restorations, not a therapeutic device itself.
No
Explanation: The device, Vericore Zirconia Blanks, is described as a material used for fabricating dental restorations (substructures, restorations, crown framework, bridge framework). It is processed by CAD/CAM or manual milling machines. There is no indication that it is used for diagnosing medical conditions or diseases.
No
The device is a physical material (zirconia blanks) used in dental fabrication, not a software program.
No, 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.
- Vericore Zirconia Blanks' Intended Use: The intended use of Vericore zirconia blanks is to fabricate dental restorations (substructures, restorations, crown frameworks, bridge frameworks). This is a manufacturing process for a medical device that will be placed in the body, not a test performed on a sample from the body.
- Device Description: The description details the material and form of the blanks used for milling, not a diagnostic test kit or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The device is a material used in the creation of a dental prosthesis, which is a medical device, but it is 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 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
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Vericore Zirconia Blanks is a device made from pre-pressed and 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
Anterior and Posterior regions (referring to dental regions for crown and bridge frameworks).
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, thermal expansion, 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 is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol depicts three overlapping human profiles facing to the right, suggesting a sense of community and care.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3, 2014
Whip Mix Corporation Mr. John P. Waters Regulatory Compliance Officer 361 Farmington Avenue Louisville KY, 40217
Re: K140877
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: April 1, 2014 Received: August 6, 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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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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 Industry and Consumer Education 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,
Mary S. Runner -S
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):___K140877
Indications for Use:
Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with 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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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: 4/1/2014
1. APPLICANT
Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217
PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: 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: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: PHONE: 502-634-5357 FAX: 502-634-4512 EMAIL: jwaters@whipmix.com DATE: 4/1/2014
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
White Peaks Copran ZR/Origin ZR (K092496)
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6. DEVICE DESCRIPTION
Vericore Zirconia Blanks is a device made from pre-pressed and 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 | White Peaks Dental Systems |
|---|---|
| Vericore Zirconia Blanks | Copran Zr/Origin YZ |
| Class II Device | Class II device |
| 510(k) Pending | 510(k)092496 |
| 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- | Copran Zr! Origin YZ Zirconia blanks are |
| sintered zirconium dioxide intended to be used | presintered blanks for CAD CAM or manual |
| with many CAD/CAM or manual milling machines. | milling, made from biocompatible, tetragonal |
| Vericore zirconia blanks are biocompatible and | and polycrystalline zirconiumdioxyde. Milling |
| designed to fabricate; | blanks designed for; |
| - Zirconia Substructures | - Crown frameworks in the anterior and |
| - Restorations (Including inlays, onlays, and | posterior areas |
| veneers) | - Bridge frameworks in the anterior and |
| - Crown Framework in the Anterior and | posterior areas |
| Posterior regions | - Primary conical crowns and telescopic |
| - Bridge Framework in the Anterior and | crowns |
| Posterior regions | - Canti-levered bridges with a max. of |
| one pontic having a premolar width |
5
| Freeholder, Callery, Callery, Canada, Callery, Canada, Carden, Carden, Carden, Carden, Carden, Carden, Carden, Carden, Carden, Carden, Carden, Carden, Carden, Carden, Carden,
---- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Onlavs, Veneers
Inlays,
l |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
9. BENCH TESTING
Flexural strength, thermal expansion, 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
Vericore® Zirconia Blanks are substantially equivalent to White Peaks ZR material in safety and effectiveness when used in accordance with the instructions for use. Both have similar Indications for Use, use the same raw material, and are biocompatible.