(112 days)
No
The device description focuses on the material properties and processing of zirconia blanks for dental prosthetics, with no mention of AI or ML. The CAD/CAM process mentioned is a standard digital manufacturing technique, not inherently AI/ML.
No.
The device is a material (zirconia blanks) used to fabricate prosthetic dental restorations (crowns and bridges), not a device that directly treats or alleviates a disease or condition.
No
The device is a material (zirconia blanks) used to create dental prostheses (crowns and bridges), not to diagnose a condition.
No
The device is a physical material (zirconia blanks) used in dental prosthetics, not a software application. While it is processed using CAD/CAM technology, the device itself is the physical blank.
Based on the provided information, 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.
- Pavati™ Zirconia Blanks' Intended Use: The intended use of Pavati™ Zirconia blanks is to create dental prostheses (crowns and bridges) for use in the mouth, not to analyze samples from the body.
- Device Description: The device description clearly states that these are materials used to fabricate physical dental restorations.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose, monitor, or screen for any medical condition. Its function is purely restorative.
Therefore, Pavati™ Zirconia blanks fall under the category of dental materials used for fabrication, not in vitro diagnostics.
N/A
Intended Use / 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".
Product codes
EIH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior/posterior applications (teeth)
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 whether the device is compliant to use. 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 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)".
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.
0
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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
5
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
| 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
6
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
CCRI/K151875 | inCoris TZI
Sirona/K123545
(Primary Device) | Prismatik™ CZ
Glidewell/K060104
(Secondary or
Reference Device) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Pavati™ Zirconia
blanks are
indicated for use in
prosthetic dentistry
to create porcelain | Classic and Speed
Sintering: Fully
anatomic crowns
and bridges in the
posterior and | The device is
indicated for use by
dental technicians in
the construction of
custom made all |
| | (ceramic)
prostheses
(crowns and
bridges). 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". | anterior tooth
region. Bridges with
max. two pontics.
Super speed
Sintering: Fully
anatomic crowns. | ceramic restorations
for anterior and
posterior locations. |
| Contra-
Indications/Warnings | • Insufficient tooth
structure reduction.
• Insufficient tooth
structure for proper
adhesion and force
distribution.
• Insufficient oral
hygiene.
• Insufficient
interproximal space
for sufficient joints in
bridges.
• Known allergies.
• Known
incompatibilities to
product composition | Insufficient oral
hygiene¹
Insufficient prep
results¹
1 as applicable to the finished
article installed by the dentist | There are no specific
precautions, warnings
or contra-indications
that are required for
the use of the device
by the dental
professional or
patient. |
| | Pavati™ Zirconia
CCRI/K151875 | inCoris TZI
Sirona/K123545
(Primary Device) | Prismatik™ CZ
Glidewell/K060104
(Secondary or
Reference Device) |
| | • Heavy
discoloration of
prepped tooth
structure.
When Pavati zirconia
blanks are milled do
not inhale dust when
removing dental
prosthesis from
dental holder take
appropriate safety | | |
| | methods such as
face mask and eye
protection. | | |
| | Technical Data (performance testing included) | | |
| Material
Composition(wt%) | Zirconia Powder
454A: | Zirconia Powder | Zirconia Powder |
| $ZrO_2+HfO_2+Y_2O_3$ | Meets ISO 13356:
2008 for Material
composition | Meets ISO 13356:
2008 for Material
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
13356:2008
Section 3, Table 1 | | | |
| | Pavati™ Zirconia
CCRI/K151875 | inCoris TZI
Sirona/K123545
(Primary Device) | Prismatik™ CZ
Glidewell/K060104
(Secondary or
Reference Device) |
| Freedom from
extraneous
materials per ISO
6872:2008 Section
5.2 active conc. of
not more than 1.0
Bq g-1 of
Uranium238 | Meets ISO
Standard | Meets ISO Standard | Not supplied |
| Blank sizes (mm) | Block: 65-85 x 40 x
15
20-55 x 19 x 15
40 x 15 x 15
14 x 13 x 15
Disc: 95-110 x 12-
30 | 110 x 80 x 10 | Disc: 98.5 x 10-30 |
| Sintered Density
(g/cm³)
ISO 13356: 2008
Section 4.1 Req't.
of ≥ 6.0 g/cm³ | Meets ISO
Standard | Meets ISO Standard | Not supplied |
| Coefficient of
thermal expansion
(CTE) ISO 6872:
2008, No req't.
report number | Meets ISO
Standard | Meets ISO Standard | Not supplied |
| Fracture
toughness Kic ISO
6872:2008 Annex
A; minimum for
class 6, 5.0 MPa
m 1/2 | Meets ISO
Standard | Meets ISO Standard | Not supplied |
| | Pavati™ Zirconia
CCRI/K151875 | inCoris TZI
Sirona/K123545
(Primary Device) | Prismatik™ CZ
Glidewell/K060104
(Secondary or
Reference Device) |
| Flexural strength
per ISO 6872:
2008, Limit
900MPa | Meets ISO
Standard | Meets ISO Standard | Meets ISO Standard |
| Chemical solubility
per ISO 6872:2008
Limit 100 µg/cm² | Meets ISO
Standard | Meets ISO Standard | Not supplied |
| Grain Size
determined per
ISO 13356:2008
No req't. for grain
size | Meets ISO
Standard | Meets ISO Standard | Not supplied |
| Amount of
monoclinic phase
shall be
determined using
X-ray diffraction
methods in
accordance with
ISO 13356:2008,
≤20% | Meets ISO
Standard | Meets ISO Standard | Not supplied |
| Biocompatibility
per ISO 10993-1:
Part 1 - 'Biological
evaluation of
medical devices –
Part 1: Evaluation
and testing within
a risk management
process." | Assured through
use of same
materials and
manufacturing
| "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." | "The biological safety
of the device has been
assured through the
selection of materials
similar in composition
to the other products
currently on the
market which have
demonstrated
appropriate levels of
biocompatibility |
| | Pavati™ Zirconia
CCRI/K151875 | inCoris TZI
Sirona/K123545
(Primary Device) | Prismatik™ CZ
Glidewell/K060104
(Secondary or
Reference Device) |
| Compliance
of the Device | Compliance is
assured by
adherence to ISO
6872:2008,
Dentistry- Ceramic
Materials and ISO
13356: 2008,
"Implants for
surgery, Ceramic
materials based on
yttria-stabilized
tetragonal zirconia
(Y-TZP)".
Validations and
testing performed
per Section 18. | Device meet ISO
6872: 2008,
"Dentistry --
Ceramic materials"
and ISO 13356:
2008, "Implants for
surgery, Ceramic
materials based on
yttria-stabilized
tetragonal zirconia
(Y-TZP)".
Physical and
chemical properties
are similar. | "The device
functions in a similar
manner to other
comparative devices
and the intended
use is the same.
The differences
between
comparative devices
are minor and do
not raise new safety
concerns. The
effectiveness and
suitability of the
device for the
intended purpose is
assured through
wide, general use of
similar other
predicate devices
that demonstrate the
safe use of the
device to construct
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.