(166 days)
No
The device is a material blank for dental prosthetics and the description focuses on its physical properties and processing via CAD/CAM, with no mention of AI/ML.
No
The device is a material blank used to create prosthetic dental devices (crowns and bridges), not a device that directly treats or prevents a disease or condition.
No
Explanation: The device, Pavati Z40.2 Zirconia blanks, is described as blanks used to create dental prostheses (crowns and bridges) in prosthetic dentistry. It is milled and sintered before use and is a material for custom restorations, not a tool for diagnosing medical conditions.
No
The device is a physical material (zirconia blanks) used in dental prosthetics, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- Device Function: The Pavati® Z40.2 Zirconia blanks are materials used to create dental prostheses (crowns and bridges). These prostheses are then placed in the patient's mouth.
- Intended Use: The intended use is to create physical dental restorations, not to perform diagnostic tests on biological samples.
- Device Description: The description clearly states they are "dental porcelain zirconia oxide blanks" that are milled and sintered to create physical dental devices.
The device is a dental material used in the fabrication of a medical device (the crown or bridge), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
Pavati® Z40.2 Zirconia blanks are in prosthetic dentistry to create porcelain (ceramic) prostheses (crowns and bridges) in the anterior/ posterior applications.
Pavati® Zirconia blanks are intended to be milled and fully sintered by Dental Professional or Dental Laboratory before use.
Product codes
EIH
Device Description
Pavati® Z40.2 Zirconia are disc and block shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patients teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patients teeth as crowns or bridges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior/ posterior applications
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental Professional or Dental Laboratory
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
CCRI performed a series of tests to assess the device. Sintered tests coupled with mechanical bench testing confirmed that the device meets specifications including established international standards and guidance documents. Density, bending strength, fracture toughness, chemical solubility and material characterization/composition of finished product was conducted to confirm that the product is meeting performance goals established by standards. Pavati® Zirconia blanks comply with ISO 6872:2015, "Dentistry – Ceramic materials" and ISO 13356: 2015, "Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)".
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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Image /page/0/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 an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a stylized representation of a serpent winding around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 12, 2016
Ccri, Inc. Robin Carden President 1319 Calle Avanzado San Clemente, California 92673
Re: K160867
Trade/Device Name: Pavati Z40.2 Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: August 10, 2016 Received: August 11, 2016
Dear Robin Carden:
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.
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 devicerelated 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.
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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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Susan Runn, 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160867
Device Name Pavati® Z40.2
Pavati® 240.2
Indications for Use (Describe)
Pavati® Z40.2 Zirconia blanks are in prosthetic dentistry to create porcelain (ceramic) prostheses (crowns and bridges) in the anterior/ posterior applications.
Pavati® Zirconia blanks are intended to be milled and fully sintered by Dental Professional or Dental Laboratory before use.
| > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ||
|---|---|---|---|
| Type of Use (Select one or both, as applicable) | |||
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
for CCRI, Inc.
Pavati® Z40.2 Zirconia
1. Submitter
CCRI, Inc. 1319 Calle Avanzado San Clemente, CA 92673 USA
Primary Contact Person:
Robin Carden President Telephone: (949) 272-7027
Secondary Contact Person:
Marilyn Pourazar RA/QA Consultant Telephone: (949) 413-7189
Date prepared: 21 March 2016
Date revised: 07 September 2016
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2. Device Name
| Proprietary Name: | Pavati® Z40.2 Zirconia |
|---|---|
| Common/Usual Name: | Powder, Porcelain |
| Classification Name: | Porcelain powder for clinical use |
| Submission Number: | K160867 |
| Regulation Number: | 21 CFR872.6600 |
| Product Code: | EIH |
| Device Classification: | Class II |
3. Predicate Devices
- Prismatik Dentalcraft BruxZir Anterior Milling Blanks-K150872 (Primary ● Predicate)
- . Prismatik Dentalcraft BruxZir Anterior-K143330 (Reference Predicate)
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4. Indications for Use
Pavati® Z40.2 Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (crowns and bridges) in the anterior/ posterior applications.
Pavati® Z40.2 Zirconia blanks are intended to be milled and fully sintered by Dental Professional or Dental Laboratory before use. Pavati® Z40.2 Zirconia blanks are for "Rx only" and not for use by the general public or sold as "Over- the-Counter".
5. Device Description and Function
Pavati® Z40.2 Zirconia are disc and block shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patients teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patients teeth as crowns or bridges.
6. Physical and Performance Characteristics
Design:
Design considerations included using current dental technology materials (Zirconium oxide) and the same manufacturing processes used throughout the world in fabrication of dental porcelain ceramic blanks. In this submission CCRI, Inc. has combined two similar products, the Prismatik Dentalcraft BruxZir Anterior Milling Blanks-K150872 (Primary Predicate) and the Prismatik Dentalcraft BruxZir Anterior-K143330 (Reference Predicate)
The Zirconia powder is acquired by an approved supplier who is a leader in production of dental ceramic material. This supplier's material is also used by many dental companies in their own formulations. Zirconia ceramic material was chosen based upon its many years of use in dental restorations by dentists, which when used is chemically/biologically practically inert.
Pavati® Z40.2 Zirconia ceramic blanks are produced by using ZrO2 powder which is combined with an organic binder (which is burnt-off during firing) and compressed into various configurations. The compressed blanks are then partially sintered (fired) at high temperatures, tested and packaged. These blanks are then sold to Dental labs or dental professionals with the capability to mill the blanks (typically using CAD/CAM techniques) into a final shape (dental restoration) and fully sintered and
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colored (if required) before patientinstallation.
Material Used:
Pavati® Z40.2 Zirconia blanks are composed of zirconia ceramics (ZrO>) based on yttria-stabilized tetragonal zirconia (Y-TZP). The material is biocompatible according to ISO 10993-1: "Biological Evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Physical Properties:
Tabulated chart of finished product "Pavati® Z40.2 Zirconia" blanks
| Sintered Density | $\geq 6.00 \text{ g cm}^3$ |
|---|---|
| Thermal Expansion coefficient (20-500°C) | 10.3 µm/m °C |
| Bending Strength | > 600 MPa |
| Grain size | 0.81 µm |
| Fracture toughness | >2.0 $\text{MPam}^{0.5}$ |
Chemical Properties:
| Component (chemical
| composition) | Pavati® Z40.2 Zirconia (percentage by wt.) |
|---|---|
| ZrO2 + HfO2 + Y2O3+Al2O3 | > 99.9 |
| Y2O3 | 9.85% ± .65 |
| Al2O3 | ≤0.1 |
| SiO2 | ≤0.02 |
| Fe2O3 | ≤0.01 |
| Chemical solubility | 300 |
| MPa | Meets ISO Standard |
| Chemical | |
| solubility per ISO | |
| 6872:2015 |