(227 days)
Not Found
No
The summary describes a dental zirconia blank used in a CAD/CAM process, which is a standard digital manufacturing technique and does not inherently involve AI/ML. There are no mentions of AI, ML, or related concepts in the text.
No.
This device is a dental blank used to create prostheses and is not intended for therapeutic purposes.
No
The device description clearly states that these are "disc and block shaped dental porcelain zirconia oxide blanks" used for "custom restorations" like crowns. This indicates it is a therapeutic or restorative device, not a diagnostic one. No mention of diagnosis is found in the "Intended Use" or "Indications for Use" section.
No
The device is a physical dental blank made of zirconia oxide, which is a hardware component. While it is used in a process involving CAD/CAM (software), the device itself is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for creating dental prostheses (crowns) for patients. This is a restorative dental application, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the material (zirconia blanks) and how it is processed (milled, sintered, colored) to create a custom dental restoration. This process is focused on fabricating a physical device for placement in the mouth.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosing a disease or condition.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the material (density, strength, fracture toughness, solubility), which are relevant to its function as a dental restoration, not a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
GenesisZr UHT700 Zirconia blanks are indicated for Monolitic-ceramic for single-unit anterior or posterior prostleses and for three-unit prostheses not involving molar restoration, adhesively cemented. Also indicated for fully covered substructure for single-unit anterior or posterior prostheses and for three-unit prostheses not involving molar restoration_adhesively, or non-adhesively cemented.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
GenesisZr® UHT700 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 patient's 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 patient's teeth as a crown.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior or posterior prostheses (teeth)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental laboratory / dental office
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
United Dental Resources Corporation performed a series of tests to assess whether the device is as safe and effective as the predicate 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 were conducted to confirm that the product is substantially equivalent in safety and effectiveness, while meeting performance goals established by standards.
GenesisZr® UHT700 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Sintered Density: ≥ 6.04 g cm3
Thermal Expansion coefficient (20-500°C): 10.2 µm/m °C
Bending Strength: > 600 MPa
Grain size: 0.66 µm
Fracture toughness: 2.4 MPa m0.5
Chemical solubility:
§ 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
January 28, 2021
United Dental Resources Corporation John Thaden Operation Officer 70 Towncenter Drive University Park, Illinois 60417
Re: K201608
Trade/Device Name: GenesisZr UHT700 Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH Dated: January 21, 2021 Received: January 25, 2021
Dear John Thaden:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo for United Dental Resources. The logo consists of a blue rectangle with the word "UNITED" in white, block letters on the top line and the words "DENTAL RESOURCES" in smaller, white letters on the bottom line. The blue rectangle is placed diagonally on top of a red parallelogram, which is slightly larger than the rectangle.
GenesisZr UHT700 ZIRCONIA 510(k) Premarket Submission
Section 4: Indications for Use Statement
Page 11 of 80
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K201608
Device Name GenesisZr UHT700 Zirconia
Indications for Use (Describe)
GenesisZr UHT700 Zirconia blanks are indicated for Monolitic-ceramic for single-unit anterior or posterior prostleses and for three-unit prostheses not involving molar restoration, adhesively cemented. Also indicated for fully covered substructure for single-unit anterior or posterior prostheses and for three-unit prostheses not involving molar restoration_adhesively, or non-adhesively cemented.
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.
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
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3
GenesisZr UHT700 ZIRCONIA 510(k) Premarket Submission
Section 5: 510(k) Summary
Image /page/3/Picture/2 description: The image shows the logo for United Dental Resources. The logo consists of a red parallelogram in the background with a blue rectangle in the foreground. The word "UNITED" is written in white, uppercase letters on the blue rectangle, with the words "DENTAL RESOURCES" written in a smaller font size below the word "UNITED".
Page 12 of 80
Section 5:
510(k) Summary
for
United Dental Resources Corporation
GenesisZr® UHT700 Zirconia
- Submitter
Owners Name:
Address:
United Dental Resources Corporation
70 Towncenter Drive University Park, IL 60484
Phone: (708) 746-5730 (888) 503-2190 Fax:
Contact Person:
John Von Thaden, Operations Officer
Date summary prepared: January 21, 2021
2. Device Name
Proprietary Name: Common/Usual Name: Classification Name: Product Code: Regulation Number: Device Class:
GenesisZr® UHT700 Zirconia Powder, Porcelain Porcelain powder for clinical use EllH 21 DFR 872.6660 Class II
3. Predicate Device
CCRI, Inc., Pavati® Z40.2 (K160867)
4. Indications for Use
GenesisZr® UHT700 Zirconia blanks are indicated for Monolithic-ceramic for singleunit anterior or posterior prostheses and for three-unit prostheses not involving molar restoration, adhesively, or non-adhesively cemented. Also indicated for fully covered substructure for single-unit anterior or posterior prostheses and for three-unit prostheses not involving molar restoration, adhesively, or non-adhesively cemented.
4
Image /page/4/Picture/1 description: The image shows the logo for United Dental Resources. The logo consists of the word "UNITED" in white letters on a blue rectangular background, with the words "DENTAL RESOURCES" in smaller white letters underneath. The blue rectangle is placed on top of a red parallelogram, which is tilted to the right. The logo has a registered trademark symbol.
5. Device Description and Function
GenesisZr® UHT700 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 patient's 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 patient's teeth as a crown.
6. Physical and Performance Characteristics
Design:
As described in Section 5.0 Device Description and Function
Material Used:
GenesisZr® UHT700 Zirconia blanks are composed of zirconia ceramics (ZrO2) based on yttria-stabilized tetragonal zirconia (Y-TZP). The material is biocompatible according to ISO 10993-1:2018 "Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
Physical Properties:
Tabulated chart of finished product "GenesisZr® UHT700 Zirconia" blanks
| Sintered Density | $\geq$ 6.04 g cm3 |
|---|---|
| Thermal Expansion coefficient (20-500°C) | 10.2 µm/m °C |
| Bending Strength | > 600 MPa |
| Grain size | 0.66 µm |
| Fracture toughness | 2.4 MPa m0.5 |
Chemical Properties:
| Component (chemical
composition) | GenesisZr® UHT700 Zirconia
(percentage by wt.) |
|-------------------------------------|---------------------------------------------------|
| ZrO2 + HfO2 + Y2O3+ Al2O3 | > 99.9 |
| Y2O3 | 9.85% ±0.65 |
| Al2O3 | ≤ 0.01 |
| SiO2 | ≤ 0.02 |
| Fe2O3 | ≤ 0.01 |
| Chemical solubility | 600MPa and a fracture toughness of 2.4 MPa m0.5, therefore limiting the device to 3-unit bridges based on the ISO 6872 standard. This has been noted in our Indications for Use. It should also be noted that the predicate device has the same contraindications for 3-unit prostheses involving molars, but the contraindication is in the directions for use for the predicate and we have opted to include it in the Indications for Use for the subject device for increased clarity. Additionally, since Indication for Use statements now note prescription requirements on the form, that has not been included in our Indications for Use statement. It is noted in the Instructions for Use and on the device labeling. Both the subject device and predicate device are provided in disc shapes of various sizes. The disc size variation of the GenesisZr® UHT700 Zirconia blanks are minor and do not affect substantial equivalence.
The subject and predicate device have similar physical/mechanical properties that meet the requirements of ISO 6872:2015.
GenesisZr® UHT700 Zirconia Biocompatibility has been assured through the use of the exact same material composition and the exact same manufacturing process as the Predicate device.
6
GenesisZr® UHT700 ZIRCONIA 510(k) Premarket Submission
Image /page/6/Picture/1 description: The image shows the logo for United Dental Resources. The logo features the word "UNITED" in white, bold letters on a blue rectangular background. Below "UNITED" are the words "DENTAL RESOURCES" in a smaller font size. The blue rectangle is placed diagonally on top of a larger red shape, which appears to be a parallelogram.
Section 5: 510(k) Summary
Page 15 of 80
| | GenesisZr® UHT700
Zirconia | Pavati® Z40.2 (K160867) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | GenesisZr UHT700 Zirconia
blanks are indicated for
Monolithic-ceramic for single-
unit anterior or posterior
prostheses and for three-unit
prostheses not involving molar
restoration, adhesively, or non-
adhesively cemented. Also
indicated for fully covered
substructure for single-unit
anterior or posterior prostheses
and for three-unit prostheses not
involving molar restoration,
adhesively, or non-adhesively
cemented. | Pavati® Z40.2 Zirconia blanks
are indicated for use in
prosthetic
dentistry to create porcelain
(ceramic) prostheses (crowns)
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". |
| Contra- Indications | Class 4 & 5 indications cannot
be made with this device. When
GenesisZr® UHT700 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. | The Device is contraindicated for
dental restorations greater than
3-units in length (per ISO
6872:2015 and the same as
reference device #1)
The device is contraindicated for
3 unit prostheses involving molar
restorations (per ISO
6872:2015). Class 4 & 5
indications cannot be made with
this device. |
| Material
Composition
% wt.
According to ISO
13356:2015
Sec. 3, Table 1 | Zirconia Powder:
ZrO2+HfO2+Y2O3+Al2O3: > 99.9
HfO2: ≤ 5.0
Y2O3: 9.85% ±0.65
Al2O3: ≤ 0.1
SiO2: ≤ 0.02
Fe2O3: ≤ 0.01 | Zirconia Powder:
ZrO2+HfO2+Y2O3+Al2O3: > 99.9
HfO2: ≤ 5.0
Y2O3: 9.85% ±0.65
Al2O3: ≤ 0.1
SiO2: ≤ 0.02
Fe2O3: ≤ 0.01 |
| Manufacturing
Process | Composition Material is acquired
in powder form. Ceramic blanks
are produced by compression.
These compressed blanks are
then partially sintered (fired) at
high temperatures. | Composition Material is acquired
in powder form. Ceramic blanks
are produced by compression.
These compressed blanks are
then partially sintered (fired) at
high temperatures. |
| | GenesisZr® UHT700
Zirconia | Pavati® Z40.2 (K160867) |
| Freedom from
extraneous materials
per ISO 6872:2015
Section 5.2 active
conc. of not more than
1.0 Bq g-1 of
Uranium238 | 2.0 MPam0.5 |
| Flexural strength per
ISO 6872:2015,
Limit >900MPa | 600 MPa | Meets ISO Standard |
| Chemical solubility
per ISO 6872:2015
Limit 100 µg/cm2 | Meets ISO Standard |