(166 days)
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".
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.
The provided text is a 510(k) Summary for a dental device, specifically Pavati® Z40.2 Zirconia blanks. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new, AI-powered diagnostic device or a device requiring clinical studies.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from this document, as it describes a material for prosthetic dentistry, not an AI/diagnostic device.
However, I can extract information related to the physical and chemical properties and their compliance with established standards, which serve as the acceptance criteria for this type of material.
Acceptance Criteria and Device Performance for Pavati® Z40.2 Zirconia
The device is a dental material, and its performance is evaluated against physical and chemical properties as defined by international standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Pavati® Z40.2 Zirconia) |
|---|---|
| Physical Properties (Sintered Product) | |
| Sintered Density (ISO 13356:2015, Req't. $\geq$ 6.00 g/cm³) | $\geq 6.00 \text{ g cm}^3$ (Meets ISO Standard) |
| Thermal Expansion Coefficient (20-500°C) (ISO 6872:2015, No req't. report number) | 10.3 µm/m °C (Meets ISO Standard) |
| Bending Strength (ISO 6872:2015, Limit >300 MPa) | > 600 MPa (Meets ISO Standard) |
| Grain Size (ISO 13356:2015, No req't. for grain size) | 0.81 µm (Meets ISO Standard) |
| Fracture Toughness KIC (ISO 6872:2015 Annex A, minimum for class 3, 2.0 MPa m$^{1/2}$) | >2.0 $\text{MPam}^{0.5}$ (Meets ISO Standard) |
| Chemical Solubility (ISO 6872:2015, < 100 µg/cm²) | < 100 µg/cm² (Meets ISO Standard) |
| Monoclinic Phase (ISO 13356:2015, $\leq$ 20%) | Meets ISO Standard |
| Chemical Properties (Percentage by weight) | |
| ZrO2 + HfO2 + Y2O3 + Al2O3 | > 99.9 |
| Y2O3 | 9.85% $\pm$ 0.65 |
| Al2O3 | $\leq$ 0.1 |
| SiO2 | $\leq$ 0.02 |
| Fe2O3 | $\leq$ 0.01 |
| Freedom from extraneous materials (ISO 6872:2015 Section 5.2, active conc. of not more than 1.0 Bq g-1 of Uranium238) | Meets ISO Standard |
| Biocompatibility | |
| ISO 10993-1: Biological evaluation of medical devices | Biocompatible and Non-toxic |
Since this document describes a dental material and not an AI or diagnostic device, the following points are not applicable and no information can be extracted or inferred from the provided text for them:
- Sample size used for the test set and the data provenance: Not applicable. Material testing often involves a fixed number of samples per test type according to standard protocols, but specific "test set" or "data provenance" in the context of diagnostic performance is not relevant here.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established through standardized laboratory measurements.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. This is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this material, the "ground truth" is defined by the physical, chemical, and biological properties measured and specified in international standards (ISO 6872:2015, ISO 13356:2015, ISO 10993-1).
- The sample size for the training set: Not applicable. This is not an AI model.
- How the ground truth for the training set was established: Not applicable. This is not an AI model.
The study that proves the device meets the acceptance criteria is detailed in Section 7, "Nonclinical Testing," and Section 6, "Physical and Performance Characteristics." CCRI performed a series of tests, including "Sintered tests coupled with mechanical bench testing," to confirm that the device meets specifications, including established international standards and guidance documents. These tests covered density, bending strength, fracture toughness, chemical solubility, and material characterization/composition on the finished product. The device's compliance with ISO 6872:2015 and ISO 13356:2015 is explicitly stated. Biocompatibility was also confirmed per ISO 10993-1.
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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) | |||
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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 (chemicalcomposition) | 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 | < 100 µg/cm² |
Performance standards used:
ISO 6872:2015, "Dentistry - Ceramic Materials"
ISO 13356:2015 "Implants for surgery, Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP)".
ISO 10993-1: "Biological evaluation of medical devices –Part 1: Evaluation and testing within a risk management process."
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7. Nonclinical Testing
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)".
Comparison to predicate devices (Table below) 8.
Pavati® Z40.2 Zirconia dental porcelain zirconium oxide blanks for use by dental professionals to construct custom dental restorations are substantially similar to the Prismatik Dentalcraft's BruxZir Anterior product lines.
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.
Both the subject device and the primary predicate device state they are indicate for use by dental professionals. Both the subject device and the primary predicate device are to be used to create prosthesis in the anterior or posterior. ISO 6872:2015 was used to support changes in the technological characteristics in the subject devices vs. the primary predicate device.
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| Deliverables | PrismatikDentalcraftBruxZir AnteriorMilling Blanks-K150872(PrimaryPredicate) | PrismatikDentalcraftBruxZir Anterior-K143330(ReferencePredicate) | Pavati® Z40.2 Zirconia(Proposed Device) |
|---|---|---|---|
| Indications forUse | The device isindicated for use bydental technicians inthe construction ofcustom made allceramic restorationsfor anterior andposterior locations. | The device isindicated for use bydental technicians inthe construction ofcustom made allceramic restorationsfor anterior andposterior locations. | Pavati® Z40.2 Zirconia blanks areindicated for use in prostheticdentistry to create porcelain (ceramic)prostheses (crowns) in the anterior/posterior applications.Pavati™ Zirconia blanks are intendedto be milled and fully sintered byDental Professional or DentalLaboratory before use. Pavati™Zirconia blanks are for "Rx only" andnot for use by the general public orsold as "Over-the- Counter. |
| Contraindications | This device iscontraindicated fordental restorationsgreater than 3-unitsin length. | There are nospecificcontraindications. | The Device is contraindicated for dentalrestorations greater than 3-units in length(per ISO 6872:2015 and the same asreference device #1)The device is contraindicated for 3 unitprostheses involving molar restorations(per ISO 6872:2015) |
| Technical Data and Performance Testing | |||
| MaterialComposition(wt%)ZrO2+HfO2+Y2O3$≥$ 99.0 HfO2: $≤$5 Y2O3: 9.85% ±.65 Al2O3: $≤$ 0.5 | Zirconia Powder | Zirconia Powder | Zirconia Powder |
| Deliverables | PrismatikDentalcraftBruxZir AnteriorMilling Blanks-K150872(PrimaryPredicate) | PrismatikDentalcraftBruxZir Anterior-K143330(ReferencePredicate) | Pavati® Z40.2 Zirconia(Proposed Device) |
| Other oxides: ≤0.5 | |||
| According to ISO13356:2015Section 3, Table 1 | |||
| Freedom fromextraneousmaterials per ISO6872:2015Section 5.2 activeconc. of not morethan 1.0 Bq g-1 ofUranium238 | Not supplied | Not supplied | Meets ISO Standard |
| Blank sizes (mm) | Not supplied | Not supplied | Block: 65-85 x 40 x 1520-55 x 19 x 1540 x 15 x 1514 x 13 x 1518 x 14.5 x 12.4Near net shapesDisc:95-110 x 12-30 |
| Sintered Density(g/cm3)ISO 13356: 2015Section 3 Table 1Req't. of ≥ 6.00 | Meets ISO Standard | Meets ISO Standard | Meets ISO Standard |
| Deliverables | PrismatikDentalcraftBruxZir AnteriorMilling Blanks-K150872(PrimaryPredicate) | PrismatikDentalcraftBruxZir Anterior-K143330(ReferencePredicate) | Pavati® Z40.2 Zirconia(Proposed Device) |
| g/cm3 | |||
| Coefficient ofthermalexpansion (CTE)ISO 6872: 2015,No req't. reportnumber | Not supplied | Not supplied | Meets ISO Standard |
| Fracturetoughness KICISO 6872:2015Annex A;minimum forclass 3, 2.0 MPam1/2 | Not supplied | Not supplied | Meets ISO Standard |
| Flexural strengthper ISO 6872:2015, Limit >300MPa | Meets ISO Standard | Meets ISO Standard | Meets ISO Standard |
| Chemicalsolubility per ISO6872:2015< 100 µg/cm2 | Not supplied | Not supplied | Meets ISO Standard |
| Deliverables | PrismatikDentalcraftBruxZir AnteriorMilling Blanks-K150872(PrimaryPredicate) | PrismatikDentalcraftBruxZir Anterior-K143330(ReferencePredicate) | Pavati® Z40.2 Zirconia(Proposed Device) |
| Grain Sizedetermined perISO 13356:2015No req't. for grainsize | Not supplied | Not supplied | Meets ISO Standard |
| Amount ofmonoclinic phaseshall bedetermined usingX-ray diffractionmethods inaccordance withISO 13356:2015,≤20% | Not supplied | Not supplied | Meets ISO Standard |
| Biocompatibilityper ISO 10993-1:Part 1 - 'Biologicalevaluation ofmedical devices -Part 1: Evaluationand testing withina riskmanagementprocess." | Biocompatible andNon-toxic | Biocompatible andNon-toxic | Biocompatible and Non-toxicAssured through use of samematerials and manufacturing methodsas legally marketed predicate devices. |
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9. Conclusion
Pavati® Z40.2 Zirconia blank comparison to the predicate devices, the Prismatik Dentalcraft BruxZir Anterior Milling Blanks-K150872 (Primary Predicate) and the Prismatik Dentalcraft BruxZir Anterior-K143330 (Reference Predicate) 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® Z40.2 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.