(112 days)
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 "Over-the-Counter".
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.
The provided text describes the regulatory clearance for the Pavati™ Zirconia dental material. It is not a study describing acceptance criteria and performance of an AI-powered medical device. The document pertains to a traditional medical device (dental material), not an algorithm or AI system. Therefore, I cannot extract the requested information regarding AI device acceptance criteria, study details, sample sizes, expert involvement, or adjudication methods, as these concepts are not relevant to this type of medical device submission.
The document discusses the physical and chemical properties of the Pavati™ Zirconia blanks and compares them to predicate devices based on established international standards for dental materials.
Here's what information can be extracted relevant to the provided document's content, rephrased to align with the prompt's structure where possible, but acknowledging it's not an AI device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ISO standards) | Reported Device Performance (Pavati™ Zirconia) |
|---|---|
| Sintered Density (ISO 13356: 2008 Section 4.1 Req't. of ≥ 6.0 g/cm³) | ≥ 6.09 g cm³ (Meets ISO Standard) |
| Thermal Expansion Coefficient (20-500°C) | 10.1 µm/m °C (Meets ISO Standard - no specific req't in ISO 6872:2008, report number only) |
| Bending Strength (ISO 6872:2008, Limit >900MPa) | > 900 MPa (Meets ISO Standard) |
| Grain size (ISO 13356:2008, no req't.) | 0.45 µm (Meets ISO Standard - no specific req't in ISO 13356:2008, determined) |
| Fracture toughness (ISO 6872:2008 Annex A; minimum for class 6, 5.0 MPa m 1/2) | 5 MPam0.5 (Meets ISO Standard) |
| Chemical solubility (ISO 6872:2008 Limit 100 µg/cm²) | 18.1 µg/cm² (Meets ISO Standard) |
| Material Composition (ZrO2+HfO2+Y2O3) (ISO 13356:2008 for Material composition, ≥ 99.0 wt%) | > 99.9% (Pavati™ Zirconia percentage by wt.) |
| Y2O3 (ISO 13356:2008, > 4.5 to ≤ 6.0 wt%) | 5.35 - 5.95 wt% |
| Al2O3 (ISO 13356:2008, ≤ 0.5 wt%) | ≤0.1 wt% |
| SiO2 | ≤0.02 wt% |
| Fe2O3 | ≤0.01 wt% |
| Freedom from extraneous materials (ISO 6872:2008 Section 5.2 active conc. of not more than 1.0 Bq g-1 of Uranium238) | Meets ISO Standard |
| Amount of monoclinic phase (ISO 13356:2008, ≤20%) | Meets ISO Standard |
| Biocompatibility (ISO 10993-1: 2009) | Assured through use of same materials and manufacturing (claims biocompatibility per ISO 10993-1:2009) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is bench testing of material properties, not a clinical trial or performance evaluation on a "test set" in the context of an AI device.
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. This is not an AI device requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" equivalent in this context is established by international standards (ISO 6872:2008 and ISO 13356:2008) for dentistry ceramic materials. These standards define the acceptable physical and chemical properties.
8. The sample size for the training set
Not applicable. This is not an AI device with a training set.
9. How the ground truth for the training set was established
Not applicable.
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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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 (chemicalcomposition) | 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™ ZirconiaCCRI/K151875 | inCoris TZISirona/K123545(Primary Device) | Prismatik™ CZGlidewell/K060104(Secondary orReference Device) | |
|---|---|---|---|
| Indications for use | Pavati™ Zirconiablanks areindicated for use inprosthetic dentistryto create porcelain | Classic and SpeedSintering: Fullyanatomic crownsand bridges in theposterior and | The device isindicated for use bydental technicians inthe construction ofcustom made all |
| (ceramic)prostheses(crowns andbridges). Pavati™Zirconia blanksare intended to bemilled and fullysintered by DentalProfessional orDental Laboratorybefore use.Pavati™ Zirconiablanks are for "Rxonly" and not foruse by the generalpublic or sold as"Over-the-Counter". | anterior toothregion. Bridges withmax. two pontics.Super speedSintering: Fullyanatomic crowns. | ceramic restorationsfor anterior andposterior locations. | |
| Contra-Indications/Warnings | • Insufficient toothstructure reduction.• Insufficient toothstructure for properadhesion and forcedistribution.• Insufficient oralhygiene.• Insufficientinterproximal spacefor sufficient joints inbridges.• Known allergies.• Knownincompatibilities toproduct composition | Insufficient oralhygiene¹Insufficient prepresults¹1 as applicable to the finishedarticle installed by the dentist | There are no specificprecautions, warningsor contra-indicationsthat are required forthe use of the deviceby the dentalprofessional orpatient. |
| Pavati™ ZirconiaCCRI/K151875 | inCoris TZISirona/K123545(Primary Device) | Prismatik™ CZGlidewell/K060104(Secondary orReference Device) | |
| • Heavydiscoloration ofprepped toothstructure.When Pavati zirconiablanks are milled donot inhale dust whenremoving dentalprosthesis fromdental holder takeappropriate safety | |||
| methods such asface mask and eyeprotection. | |||
| Technical Data (performance testing included) | |||
| MaterialComposition(wt%) | Zirconia Powder454A: | Zirconia Powder | Zirconia Powder |
| $ZrO_2+HfO_2+Y_2O_3$ | Meets ISO 13356:2008 for Materialcomposition | Meets ISO 13356:2008 for Materialcomposition | 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 ISO13356:2008Section 3, Table 1 | |||
| Pavati™ ZirconiaCCRI/K151875 | inCoris TZISirona/K123545(Primary Device) | Prismatik™ CZGlidewell/K060104(Secondary orReference Device) | |
| Freedom fromextraneousmaterials per ISO6872:2008 Section5.2 active conc. ofnot more than 1.0Bq g-1 ofUranium238 | Meets ISOStandard | Meets ISO Standard | Not supplied |
| Blank sizes (mm) | Block: 65-85 x 40 x1520-55 x 19 x 1540 x 15 x 1514 x 13 x 15Disc: 95-110 x 12-30 | 110 x 80 x 10 | Disc: 98.5 x 10-30 |
| Sintered Density(g/cm³)ISO 13356: 2008Section 4.1 Req't.of ≥ 6.0 g/cm³ | Meets ISOStandard | Meets ISO Standard | Not supplied |
| Coefficient ofthermal expansion(CTE) ISO 6872:2008, No req't.report number | Meets ISOStandard | Meets ISO Standard | Not supplied |
| Fracturetoughness Kic ISO6872:2008 AnnexA; minimum forclass 6, 5.0 MPam 1/2 | Meets ISOStandard | Meets ISO Standard | Not supplied |
| Pavati™ ZirconiaCCRI/K151875 | inCoris TZISirona/K123545(Primary Device) | Prismatik™ CZGlidewell/K060104(Secondary orReference Device) | |
| Flexural strengthper ISO 6872:2008, Limit>900MPa | Meets ISOStandard | Meets ISO Standard | Meets ISO Standard |
| Chemical solubilityper ISO 6872:2008Limit 100 µg/cm² | Meets ISOStandard | Meets ISO Standard | Not supplied |
| Grain Sizedetermined perISO 13356:2008No req't. for grainsize | Meets ISOStandard | Meets ISO Standard | Not supplied |
| Amount ofmonoclinic phaseshall bedetermined usingX-ray diffractionmethods inaccordance withISO 13356:2008,≤20% | Meets ISOStandard | Meets ISO Standard | Not supplied |
| Biocompatibilityper ISO 10993-1:Part 1 - 'Biologicalevaluation ofmedical devices –Part 1: Evaluationand testing withina risk managementprocess." | Assured throughuse of samematerials andmanufacturing | "The material isbiocompatibleaccording to ISO10993-1:2009,'Biologicalevaluation ofmedical devices –Part 1: Evaluationand testing within arisk managementprocess." | "The biological safetyof the device has beenassured through theselection of materialssimilar in compositionto the other productscurrently on themarket which havedemonstratedappropriate levels ofbiocompatibility |
| Pavati™ ZirconiaCCRI/K151875 | inCoris TZISirona/K123545(Primary Device) | Prismatik™ CZGlidewell/K060104(Secondary orReference Device) | |
| Complianceof the Device | Compliance isassured byadherence to ISO6872:2008,Dentistry- CeramicMaterials and ISO13356: 2008,"Implants forsurgery, Ceramicmaterials based onyttria-stabilizedtetragonal zirconia(Y-TZP)".Validations andtesting performedper Section 18. | Device meet ISO6872: 2008,"Dentistry --Ceramic materials"and ISO 13356:2008, "Implants forsurgery, Ceramicmaterials based onyttria-stabilizedtetragonal zirconia(Y-TZP)".Physical andchemical propertiesare similar. | "The devicefunctions in a similarmanner to othercomparative devicesand the intendeduse is the same.The differencesbetweencomparative devicesare minor and donot raise new safetyconcerns. Theeffectiveness andsuitability of thedevice for theintended purpose isassured throughwide, general use ofsimilar otherpredicate devicesthat demonstrate thesafe use of thedevice to constructdental 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.
§ 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.