(123 days)
Not Found
No
The description focuses on the material properties and manufacturing process (CAD/CAM milling and sintering) of the zirconia blanks, with no mention of AI or ML for design, analysis, or any other function.
No.
The device is a raw material (zirconia blanks) used for fabricating dental prostheses such as crowns, bridges, and dentures. While these prostheses are therapeutic devices, the blanks themselves are not directly applied to a patient for therapeutic purposes until they are milled and sintered into a finished product.
No
This device is a material (zirconia blanks) used to fabricate dental prostheses, not to diagnose a medical condition.
No
The device is a physical material (zirconia blanks) used to create dental prostheses, not a software application. While it is processed using CAD/CAM (which involves software), the device itself is the physical blank.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the GenesisZr™ 4Y Zirconia blanks is to create dental prostheses (dentures, crowns, and bridges) that are placed in the patient's mouth. They are not used to test or analyze samples like blood, urine, or tissue.
- The device description clearly outlines its use in creating physical restorations. The process involves milling, sintering, and fitting the blanks to the patient's teeth. This is a manufacturing process for a medical device, not a diagnostic test.
- The performance studies focus on material properties and mechanical strength. The tests mentioned (density, bending strength, fracture toughness, chemical solubility) are relevant to the physical performance and durability of the dental prosthesis, not to the accuracy or reliability of a diagnostic test.
The GenesisZr™ 4Y Zirconia blanks are a dental material used to fabricate medical devices (dental prostheses). They are not used for diagnosis.
N/A
Intended Use / Indications for Use
GenesisZr™ 4Y Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). GenesisZr™ 4Y Zirconia blanks are intended to be milled and fully sintered before use for:
- Full contour monolithic crowns and bridges in anterior and posterior regions.
- Anatomically reduced for veneering, crown and bridge frames.
- Bridge to be limited to 3 units with a maximum of 1 pontic.
Product codes
EIH
Device Description
GenesisZr™ 4Y Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in one color, white, and various sizes that are used in customized 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 customized rendered blank is milled the device is fully sintered and colored (if required) and fitted to the patient's teeth as dentures, crowns or bridges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior and posterior regions (for full contour monolithic crowns and bridges), teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prosthetic dentistry, dental laboratory, dental professional (DDS or DMD)
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. 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 while meeting performance goals established by standards. GenesisZr™ 4Y Zirconia blanks comply with ISO 6872:2008, "Dentistry - Ceramic materials" and ISO 13356: 2008, "Implants for surgery, Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP)". A risk management evaluation was done in which the materials, manufacturing processes and use were evaluated per the FDA Guidance, Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Sintered Density g/cm3: 6.09 g/cm³ (Requirement ≥ 6.0)
- Coefficient of thermal expansion (CTE): 10.2 µm/m °C
- Fracture toughness Kıc: 3.5 MPa m0.5
- Flexural strength: 1100 MPa (Limit >900MPa)
- Chemical solubility: 6.0 µg/cm² (Limit 100 ug/cm²)
Predicate Device(s)
Reference Device(s)
Not Found
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/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
United Dental Resources Corporation John Von Thaden Operations Officer 70 Towncenter Drive University Park, Illinois 60484
January 25, 2019
Re: K182642
Trade/Device Name: GenesisZr™ 4Y Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: October 22, 2018 Received: October 29, 2018
Dear John Von 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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 Date: 2019.01.25
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182642
Device Name GenesisZr™ 4Y Zirconia
Indications for Use (Describe)
GenesisZr™ 4Y Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). GenesisZr™ 4Y Zirconia blanks are intended to be milled and fully sintered before use for:
- Full contour monolithic crowns and bridges in anterior and posterior regions.
- Anatomically reduced for veneering, crown and bridge frames.
- Bridge to be limited to 3 units with a maximum of 1 pontic.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for United Dental Resources. The logo features the word "UNITED" in white letters on a blue rectangular background. Below "UNITED" are the words "DENTAL RESOURCES" in a smaller font. The blue rectangle is placed diagonally on top of a red shape, which appears to be a parallelogram or a rectangle tilted to the side.
510(k) Summary
for
United Dental Resources Corporation
GenesisZr™ 4Y Zirconia
1. Submitter
| Owner's Name: | United Dental Resources Corporation |
|---|---|
| Address: | 70 Towncenter Drive |
| University Park, IL USA 60484 | |
| Phone: | 1-708-746-5730 |
| Fax number: | 1-888-503-2190 |
| Contact Person: | John Von Thaden, Operations |
| Date summary prepared: | January 25, 2019 |
2. Device Name and Classification
| Proprietary/Trade Name: | GenesisZr™ 4Y Zirconia |
|---|---|
| Common/Usual Name: | Powder, Porcelain |
| Classification Name: | Porcelain Powder for Clinical Use |
| Product Code: | EIH |
| Regulation Number: | 21 CFR 872.6660 |
| Device Class: | Class II |
3. Predicate Device
Glidewell Laboratories, Prismatik™ Clinical Zirconia (Prismatik™ CZ) (K060104)
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Image /page/4/Picture/0 description: The image shows the logo for United Dental Resources. The logo features the word "UNITED" in blue, bold letters on a blue rectangular background. Below "UNITED" are the words "DENTAL RESOURCES" in smaller, white letters. The blue rectangle is placed diagonally on top of a red shape that resembles a skewed rectangle.
4. Indications for Use
GenesisZr™ 4Y Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). GenesisZr™ 4Y Zirconia blanks are intended to be milled and fully sintered before use for:
- Full contour monolithic crowns and bridges in anterior and posterior regions.
- Anatomically reduced for veneering, crown and bridge frames.
- Bridge to be limited to 3 units with a maximum of 1 pontic.
5. Device Description and Function
GenesisZr™ 4Y Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in one color, white, and various sizes that are used in customized 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 customized rendered blank is milled the device is fully sintered and colored (if required) and fitted to the patient's teeth as dentures, crowns or bridges.
6. Substantial Equivalence Discussion
| | GenesisZrTM 4Y Zirconia | PrismatikTM CZ
Glidewell/K060104 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | GenesisZrTM 4Y Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). GenesisZrTM 4Y Zirconia blanks are intended to be milled and fully sintered before use for:
- Full contour monolithic crowns and bridges in anterior and posterior regions.
- Anatomically reduced for veneering, crown and bridge frames.
- Bridge to be limited to 3 units with a maximum of 1 pontic. | For use in prosthetic dentistry to create porcelain (ceramic) protheses.
For use only by or on the order of a dental professional such as a DDS or DMD. Not for use by the general public or OTC. |
| Contra-Indications | Class 5 indications cannot be made with this device. When GenesisZrTM 4Y 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. | There are no specific precautions, warnings or contra-indications |
| | GenesisZr™ 4Y Zirconia | Prismatik™ CZ
Glidewell/K060104 |
| Material Composition
% wt. | Zirconia Powder:
ZrO2+HfO2+Y2O3: >99
Y2O3: 6.9
Al2O3: ≤ 0.05
SiO2: ≤0.002
Fe2O3: ≤0.002 | Zirconia Powder:
ZrO2+HfO2+Y2O3: > 99
HfO2: 900MPa | 1100 MPa | 1100MPa |
| Chemical solubility per
ISO 6872:2008 Limit 100
ug/cm² | 6.0 µg/cm² | N/A |
| Biocompatibility per ISO
10993-1: Part 1 -
'Biological evaluation of
medical devices -Part 1:
Evaluation and testing
within a risk management
process." | Biocompatibility risk management
analysis was conducted per ISO
10993-1 of the materials and
manufacturing methods to legally
marketed predicate devices. | N/A |
| Blank sizes(mm) | Disc: | Disc sizes |
| | 95-110mm x 10-30mm | 98.5 x 10-30mm |
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Image /page/5/Picture/0 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. The blue rectangle is set against a red background, which is angled to the left and extends beyond the blue rectangle on both sides.
GenesisZr™ 4Y Zirconia blank comparison to the predicate device, Glidewell Prismatik™ Clinical Zirconia (Prismatik™ CZ) (K060104), is based upon similar characteristics such as: intended use, indications, contra-indications, material properties, chemical composition,
6
Image /page/6/Picture/0 description: The image shows the logo for United Dental Resources. The logo features the word "UNITED" in white, bold, sans-serif font on a blue rectangular background. Below "UNITED" is the phrase "DENTAL RESOURCES" in a smaller, white, sans-serif font. The blue rectangle is placed on top of a red shape that resembles a parallelogram, and the entire logo is slightly tilted.
processing/fabrication and testing to recognized standards and guidelines. GenesisZr™ utilizes a greater composition of Y>O3 which is added for extra translucency, but results in a fracture toughness of 3.5 MPa m85, therefore limiting the device to 3-unit bridges based on the ISO 6872 standard. This has been noted in our Indications for Use. However, this difference due to the addition of a specification in the Indications for Use does not affect substantial equivalence. 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 shape of various sizes. The disc size of the GenesisZr™ Zirconia blanks are minor and do not affect substantial equivalence. The subject and predicate device have similar physical/mechanical properties that met the requirements of ISO 6872.
7. Nonclinical Testing
United Dental Resources Corporation performed a series of tests. 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 while meeting performance goals established by standards. GenesisZr™ 4Y Zirconia blanks comply with ISO 6872:2008, "Dentistry - Ceramic materials" and ISO 13356: 2008, "Implants for surgery, Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP)". A risk management evaluation was done in which the materials, manufacturing processes and use were evaluated per the FDA Guidance, Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016.
8. Clinical Testing
Clinical tests have not been performed.
- Conclusion: GenesisZr™ 4Y Zirconia blank comparison to the predicate device. 9. Glidewell Prismatik™ Clinical Zirconia (Prismatik™ CZ) (K060104), is based upon similar characteristics such as: intended use, indications, contra-indications, material properties, chemical composition, processing/fabrication and testing to recognized standards and quidelines, United Dental Resources believes that GenesisZr™ 4Y Zirconia blanks are substantially equivalent to legally marketed predicate devices.