Pavati Zirconia
Device Facts
| Record ID | K151875 |
|---|---|
| Device Name | Pavati Zirconia |
| Applicant | Ccri, Inc. |
| Product Code | EIH · Dental |
| Decision Date | Oct 29, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6660 |
| Device Class | Class 2 |
Indications for Use
Pavati™ Zirconia blanks are indicated for use 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. Pavat™ Zirconia blanks are for "Rx only" and not for use by the general public or sold as "Over-the-Counter".
Device Story
Pavati™ Zirconia consists of yttria-stabilized tetragonal zirconia (Y-TZP) discs and blocks. Used by dental laboratories to fabricate custom dental restorations (crowns and bridges). Input: anatomical rendering of patient teeth from dental office. Transformation: laboratory uses CAD/CAM milling to shape blank; subsequent full sintering and optional coloring. Output: finished ceramic dental prosthesis. Context: professional dental laboratory environment. Benefit: provides biocompatible, high-strength ceramic material for restorative dentistry.
Clinical Evidence
No clinical data. Evidence is based on bench testing of sintered product, including density, bending strength, fracture toughness, chemical solubility, and material characterization. Testing confirmed compliance with ISO 6872:2008 and ISO 13356:2008.
Technological Characteristics
Material: Yttria-stabilized tetragonal zirconia (Y-TZP). Form factor: Discs and blocks. Standards: ISO 6872:2008 (Dentistry - Ceramic Materials), ISO 13356:2008 (Implants for surgery, Y-TZP), ISO 10993-1:2009 (Biocompatibility). Processing: CAD/CAM milling followed by full sintering. Biocompatible, chemically inert.
Indications for Use
Indicated for dental professionals or laboratories to create porcelain (ceramic) crowns and bridges in anterior/posterior applications. Contraindications include insufficient tooth structure reduction, insufficient structure for adhesion/force distribution, poor oral hygiene, insufficient interproximal space for bridge joints, known allergies, and known incompatibilities to product composition.
Regulatory Classification
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.
Predicate Devices
Reference Devices
- Prismatik™ CZ (K060104)
Submission Summary (Full Text)
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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 image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2015
CCRI, Inc. Ms. Robin Carden President 1319 Calle Avanzado San Clemente, California 92673
Re: K151875
Trade/Device Name: Pavati™ Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: July 30, 2015 Received: August 3, 2015
### Dear Ms. 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.
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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 (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/MedicalDevices/Resourcesfor You/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,
Tina Kiang -
for 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) K151875
Device Name Pavati Zirconia
### Indications for Use (Describe)
Pavati™ Zirconia blanks are indicated for use 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. Pavat™ Zirconia blanks are for "Rx only" and not for use by the general public or sold as "Over-the-Counter".
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
for CCRI, Inc.
# Pavati™ Zirconia
#### 1. Submitter
CCRI, Inc.
1319 Calle Avanzado
San Clemente, CA 92673
USA
Contact Person: Robin Carden
Telephone: (949) 366-5221
Date prepared: 28JUL2015
#### Device Name 2.
Proprietary Name: Pavati™ Zirconia Common/Usual Name: Powder, Porcelain Classification Name: Porcelain powder for clinical use Submission Number: K151875 product code EIH
#### 3. Predicate Devices
Glidewell Prismatik™ Clinical Zirconia (Prismatik™ CZ), (K062509) and Sirona inCoris TZI (K123545)
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#### 4. Indications for Use
Pavati™ Zirconia blanks are indicated for use 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. Pavati™ Zirconia blanks are for "Rx only" and not for use by the general public or sold as "Overthe-Counter".
#### Device Description and Function 5.
Pavati™ 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.
#### Physical and Performance Characteristics 6.
## 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 from two companies. In the inCoris TZI (Primary Device) the blanks are in a block configuration while the Prismatik CZ (Reference Device) is offered in a disc configuration.
The Zirconia powder is acquired by an approved supplier. 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™ Zirconia ceramic blanks are produced by using ZrO2 (Zirconium oxide) 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
CCRI, Inc. 510(k) Pavati™ Zirconia
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blanks (typically using CAD/CAM techniques) into a final shape (dental restoration) and fully sintered and colored (if required) before patientinstallation.
## Material Used:
Pavati™ Zirconia blanks are composed of zirconia ceramics (ZrO2) based on yttria-stabilized tetragonal zirconia (Y-TZP). The material is biocompatible according to ISO 10993-1: 2009 "Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
## Physical Properties:
Tabulated chart of finished product "Pavati™ Zirconia" blanks
| Sintered Density | ≥ 6.09 g cm³ |
|------------------------------------------|--------------|
| Thermal Expansion coefficient (20-500°C) | 10.1 µm/m °C |
| Bending Strength | > 900 MPa |
| Grain size | 0.45 µm |
| Fracture toughness | 5 MPam0.5 |
### Chemical Properties:
| Component (chemical<br>composition) | Pavati™ Zirconia (percentage by wt.) |
|-------------------------------------|--------------------------------------|
| ZrO2 + HfO2 + Y2O3+ Al2O3 | > 99.9 |
| Y2O3 | 5.35 - 5.95 |
| Al2O3 | ≤0.1 |
| SiO2 | ≤0.02 |
| Fe2O3 | ≤0.01 |
| Chemical solubility | 18.1 µg/cm² |
## Performance standards used:
ISO 6872:2008, "Dentistry - Ceramic Materials"
ISO 13356:2008 "Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)".
ISO 10993-1: 2009 – "Biological evaluation of medical devices –Part 1: Evaluation and testing within a risk management process."
#### Nonclinical Testing 7.
CCRI performed a series of tests to assess whether the device is compliant to use. Sintered tests coupled with mechanical bench testing confirmed
CCRI, Inc. 510(k) Pavati™ Zirconia
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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 equivalent while meeting performance goals established by standards. Pavati™ Zirconia blanks comply with ISO 6872:2008, "Dentistry - Ceramic materials" and ISO 13356: 2008, "Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)".
#### 8. Clinical Testing
Clinical tests have not been performed.
#### 9. Comparison to predicate devices (Table below)
Pavati™ Zirconia dental porcelain zirconium oxide blanks for use by dental professionals to construct custom dental restorations are substantially similar to the Glidewell Prismatik™CZ and Sirona inCoris TZI in general composition.
The inCoris TZI "Indications for use" are in the final fully sintered form for installation in the patient. While the Prismatik™ CZ "Indications for use" are more general in description and the Pavati zirconia blanks are in a partial sintered form in which the dental laboratory finishes the blanks according to CCRI instructions provided in the "Instructions for use". All product testing by CCRI has been done on full sintered product to assure the end user that the performance specifications, of the product comply with established consensus standards and are similar to the conditions of ceramic manufacture as the predicate devices.
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| | Pavati™ Zirconia<br>CCRI/K151875 | inCoris TZI<br>Sirona/K123545<br>(Primary Device) | Prismatik™ CZ<br>Glidewell/K060104<br>(Secondary or<br>Reference Device) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Pavati™ Zirconia<br>blanks are<br>indicated for use in<br>prosthetic dentistry<br>to create porcelain | Classic and Speed<br>Sintering: Fully<br>anatomic crowns<br>and bridges in the<br>posterior and | The device is<br>indicated for use by<br>dental technicians in<br>the construction of<br>custom made all |
| | (ceramic)<br>prostheses<br>(crowns and<br>bridges). Pavati™<br>Zirconia blanks<br>are intended to be<br>milled and fully<br>sintered by Dental<br>Professional or<br>Dental Laboratory<br>before use.<br>Pavati™ Zirconia<br>blanks are for "Rx<br>only" and not for<br>use by the general<br>public or sold as<br>"Over-the-<br>Counter". | anterior tooth<br>region. Bridges with<br>max. two pontics.<br>Super speed<br>Sintering: Fully<br>anatomic crowns. | ceramic restorations<br>for anterior and<br>posterior locations. |
| Contra-<br>Indications/Warnings | • Insufficient tooth<br>structure reduction.<br>• Insufficient tooth<br>structure for proper<br>adhesion and force<br>distribution.<br>• Insufficient oral<br>hygiene.<br>• Insufficient<br>interproximal space<br>for sufficient joints in<br>bridges.<br>• Known allergies.<br>• Known<br>incompatibilities to<br>product composition | Insufficient oral<br>hygiene¹<br>Insufficient prep<br>results¹<br><span style="font-size: smaller;">1 as applicable to the finished<br/>article installed by the dentist</span> | There are no specific<br>precautions, warnings<br>or contra-indications<br>that are required for<br>the use of the device<br>by the dental<br>professional or<br>patient. |
| | Pavati™ Zirconia<br>CCRI/K151875 | inCoris TZI<br>Sirona/K123545<br>(Primary Device) | Prismatik™ CZ<br>Glidewell/K060104<br>(Secondary or<br>Reference Device) |
| | • Heavy<br>discoloration of<br>prepped tooth<br>structure.<br>When Pavati zirconia<br>blanks are milled do<br>not inhale dust when<br>removing dental<br>prosthesis from<br>dental holder take<br>appropriate safety | | |
| | methods such as<br>face mask and eye<br>protection. | | |
| | Technical Data (performance testing included) | | |
| Material<br>Composition(wt%) | Zirconia Powder<br>454A: | Zirconia Powder | Zirconia Powder |
| $ZrO_2+HfO_2+Y_2O_3$ | Meets ISO 13356:<br>2008 for Material<br>composition | Meets ISO 13356:<br>2008 for Material<br>composition | Not supplied |
| ≥ 99.0 | | | |
| $HfO_2$ : ≤ 5 | | | |
| $Y_2O_3$ : > 4.5 to ≤ 6.0 | | | |
| $Al_2O_3$ : ≤ 0.5 | | | |
| Other oxides: ≤0.5 | | | |
| According to ISO<br>13356:2008<br>Section 3, Table 1 | | | |
| | Pavati™ Zirconia<br>CCRI/K151875 | inCoris TZI<br>Sirona/K123545<br>(Primary Device) | Prismatik™ CZ<br>Glidewell/K060104<br>(Secondary or<br>Reference Device) |
| Freedom from<br>extraneous<br>materials per ISO<br>6872:2008 Section<br>5.2 active conc. of<br>not more than 1.0<br>Bq g-1 of<br>Uranium238 | Meets ISO<br>Standard | Meets ISO Standard | Not supplied |
| Blank sizes (mm) | Block: 65-85 x 40 x<br>15<br>20-55 x 19 x 15<br>40 x 15 x 15<br>14 x 13 x 15<br>Disc: 95-110 x 12-<br>30 | 110 x 80 x 10 | Disc: 98.5 x 10-30 |
| Sintered Density<br>(g/cm³)<br>ISO 13356: 2008<br>Section 4.1 Req't.<br>of ≥ 6.0 g/cm³ | Meets ISO<br>Standard | Meets ISO Standard | Not supplied |
| Coefficient of<br>thermal expansion<br>(CTE) ISO 6872:<br>2008, No req't.<br>report number | Meets ISO<br>Standard | Meets ISO Standard | Not supplied |
| Fracture<br>toughness Kic ISO<br>6872:2008 Annex<br>A; minimum for<br>class 6, 5.0 MPa<br>m 1/2 | Meets ISO<br>Standard | Meets ISO Standard | Not supplied |
| | Pavati™ Zirconia<br>CCRI/K151875 | inCoris TZI<br>Sirona/K123545<br>(Primary Device) | Prismatik™ CZ<br>Glidewell/K060104<br>(Secondary or<br>Reference Device) |
| Flexural strength<br>per ISO 6872:<br>2008, Limit<br>>900MPa | Meets ISO<br>Standard | Meets ISO Standard | Meets ISO Standard |
| Chemical solubility<br>per ISO 6872:2008<br>Limit 100 µg/cm² | Meets ISO<br>Standard | Meets ISO Standard | Not supplied |
| Grain Size<br>determined per<br>ISO 13356:2008<br>No req't. for grain<br>size | Meets ISO<br>Standard | Meets ISO Standard | Not supplied |
| Amount of<br>monoclinic phase<br>shall be<br>determined using<br>X-ray diffraction<br>methods in<br>accordance with<br>ISO 13356:2008,<br>≤20% | Meets ISO<br>Standard | Meets ISO Standard | Not supplied |
| Biocompatibility<br>per ISO 10993-1:<br>Part 1 - 'Biological<br>evaluation of<br>medical devices –<br>Part 1: Evaluation<br>and testing within<br>a risk management<br>process." | Assured through<br>use of same<br>materials and<br>manufacturing<br> | "The material is<br>biocompatible<br>according to ISO<br>10993-1:2009,<br>'Biological<br>evaluation of<br>medical devices –<br>Part 1: Evaluation<br>and testing within a<br>risk management<br>process." | "The biological safety<br>of the device has been<br>assured through the<br>selection of materials<br>similar in composition<br>to the other products<br>currently on the<br>market which have<br>demonstrated<br>appropriate levels of<br>biocompatibility |
| | Pavati™ Zirconia<br>CCRI/K151875 | inCoris TZI<br>Sirona/K123545<br>(Primary Device) | Prismatik™ CZ<br>Glidewell/K060104<br>(Secondary or<br>Reference Device) |
| Compliance<br>of the Device | Compliance is<br>assured by<br>adherence to ISO<br>6872:2008,<br>Dentistry- Ceramic<br>Materials and ISO<br>13356: 2008,<br>"Implants for<br>surgery, Ceramic<br>materials based on<br>yttria-stabilized<br>tetragonal zirconia<br>(Y-TZP)".<br>Validations and<br>testing performed<br>per Section 18. | Device meet ISO<br>6872: 2008,<br>"Dentistry --<br>Ceramic materials"<br>and ISO 13356:<br>2008, "Implants for<br>surgery, Ceramic<br>materials based on<br>yttria-stabilized<br>tetragonal zirconia<br>(Y-TZP)".<br>Physical and<br>chemical properties<br>are similar. | "The device<br>functions in a similar<br>manner to other<br>comparative devices<br>and the intended<br>use is the same.<br>The differences<br>between<br>comparative devices<br>are minor and do<br>not raise new safety<br>concerns. The<br>effectiveness and<br>suitability of the<br>device for the<br>intended purpose is<br>assured through<br>wide, general use of<br>similar other<br>predicate devices<br>that demonstrate the<br>safe use of the<br>device to construct<br>dental restorations." |
CCRI, Inc. 510(k) Pavati™ Zirconia
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#### 10. Conclusion
Pavati™ Zirconia blank comparison to the predicate devices Glidewell Prismatik™ Clinical Zirconia (Prismatik™ CZ K060104) and Sirona inCoris TZI (K123545) is based upon similar characteristics such as: intended use, indications, contra-indications, material properties, chemical composition, processing/fabrication and testing to recognized standards and guidelines. CCRI, Inc. believes that Pavati™ Zirconia blanks are substantially equivalent to these legally marketed predicate devices.
