(228 days)
Not Found
No
The device description focuses on the material (zirconia blanks) and the manufacturing process (CAD/CAM milling, sintering, coloring). There is no mention of AI or ML in the intended use, device description, or performance studies. The CAD/CAM process described is a standard digital manufacturing workflow, not inherently AI/ML driven.
No
The device is a material (zirconia blanks) used to fabricate custom dental restorations, not a device that directly administers therapy or treatment.
No
The device is a zirconia blank used for creating dental restorations, not for diagnosing medical conditions.
No
The device description clearly states it is a physical product (zirconia blanks) used in a milling process, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the production of dental restorations (crowns, bridges, copings) for patients. This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The device is a material (zirconia blanks) that is processed and fitted to the patient's teeth. It is not used to analyze a sample from the human body to provide information about a physiological state, health, disease, or congenital abnormality.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose any condition or provide any diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide diagnostic information. This device is a material used in vivo (in the body) as a dental restoration.
N/A
Intended Use / Indications for Use
GenesisZr® 4Y+(ST1100) Zirconia blanks are indicated for use by dental technicians for the production of full contour and substructures restorations up to a full arch.
Product codes
EIH
Device Description
GenesisZr® 4Y+ (ST1100) 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, bridge or coping.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's teeth as a crown, bridge or coping.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental technicians
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 safe and effective 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 safe and effective, while meeting performance goals established by standards.
GenesisZr® 4Y+ (ST1100) 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: ≥ 6.07 g/cm³
Thermal Expansion coefficient (20-500°C): 10.2 µm/m °C
Bending Strength: 1,100 MPa
Grain size: 0.66 µm
Fracture toughness: >5.0 MPam0.5
ZrO2 + HfO2 + Y2O3+ Al2O3: > 99.0 wt%
Al2O3: ≤ 0.05 wt%
SiO2: ≤ 0.01 wt%
Fe2O3: ≤ 0.01 wt%
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 23, 2021
John Von Thaden, Operations Officer United Dental Resources Corporation 70 Towncenter Drive University Park, Illinois 60484
Re: K201915
Trade/Device Name: GenesisZr 4Y+(ST1100) Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: October 10, 2020 Received: October 14, 2020
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 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
1
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 mediation-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. Adiodha. 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
Indications for Use
510(k) Number (if known) K201915
Device Name
GenesisZr® 4Y+(ST1100) Zirconia
Indications for Use (Describe)
GenesisZn® 4Y+(ST1100) Zirconia blanks are indicated for use by dental technicians for the production of full contour and substructures restorations up to a full arch.
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) |
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3
enesisZr® 4Y+ (ST1100) ZIRCONIA 510(k) Premarket Submission
Section 5: 510(k) Summary
Page 13 of 84
Image /page/3/Picture/3 description: The image shows the text "Section 5:". The text is written in a large, bold font and is black in color. The background of the image is white.
510(k) Summary
for
United Dental Resources Corporation
GenesisZr® 4Y+ (ST1100) Zirconia
1. Submitter
Owners Name: United Dental Resources Corporation Address: 70 Towncenter Drive University Park, IL 60484
| Phone: | (708) 746-5730 |
|---|---|
| Fax: | (888) 503-2190 |
Contact Person:
John Von Thaden, Operations Officer
January 21, 2020
Date summary prepared:
2. Device Name
Proprietary Name: Common/Usual Name: Classification Name: Product Code: Requlation Number: Device Class:
GenesisZr® 4Y+ (ST1100) Zirconia Powder, Porcelain Porcelain powder for clinical use EIH 21 DFR 872.6660 Class II
3. Predicate Device
The Argen Corporation, ArgenZ HT+ (K190079)
4. Indications for Use
GenesisZr® 4Y+ (ST1100) Zirconia blanks are indicated for use by dental technicians for the production of full contour and substructures restorations up to a full arch.
4
enesisZr® 4Y+ (ST1100) ZIRCONIA 510(k) Premarket Submission
Section 5: 510(k) Summary
Page 14 of 84
5. Device Description and Function
GenesisZr® 4Y+ (ST1100) 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, bridge or coping.
6. Physical and Performance
Characteristics Design:
As described in Section 5.0 above - Device Description and Function
Material Used:
GenesisZr® 4Y+ (ST1100) 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 "GenesisZr® 4Y+ (ST1100) Zirconia" blanks (see next page)
| Sintered Density | ≥ 6.07 g/cm³ |
|---|---|
| Thermal Expansion coefficient (20-500°C) | 10.2 µm/m °C |
| Bending Strength | 1,100 MPa |
| Grain size | 0.66 µm |
| Fracture toughness | >5.0 MPam0.5 |
Chemical Properties:
| Component (chemical
composition) | GenesisZr® 4Y+ (ST1100) Zirconia
(percentage by wt.) |
|-------------------------------------|---------------------------------------------------------|
| ZrO2 + HfO2 + Y2O3+ Al2O3 | > 99.0 |
| Al2O3 | ≤ 0.05 |
| SiO2 | ≤ 0.01 |
| Fe2O3 | ≤ 0.01 |
| Chemical solubility | 99), which results in a flexural strength of >1,100MPa and a fracture toughness of >5.0 MPa m0.5, therefore allowing for a classification of Class 5 in the ISO 6872:2015 standard. Thus the product meets the standards for "Monolithic-ceramic for prostheses involving four or more units or fully covered substructure for prostheses involving four or more units."
The predicate device's Indications for Use provide for "the production of full contour and substructure restorations up to a full arch" and the subject device also meets the standards for this same indication based upon the specification with ISO 6872:2015, Section 4 and Annex A.
Additionally, while indication for Use statements now note prescription requirements on the form, we have still indicated the device is for use by dental technicians. We have also noted the prescription requirements in the Instructions for Use (Section 13) and on the device labeling (Section 13). Both the subject device and predicate device
6
enesisZr® 4Y+ (ST1100) ZIRCONIA 510(k) Premarket Submission Section 5: 510(k) Summary Page 16 of 84
are provided in disc shapes of various sizes.
The subject and predicate device have similar physical/mechanical properties that meet the requirements of ISO 6872:2015.
GenesisZr® 4Y+ (ST1100) Zirconia Biocompatibility has been assured through the use of the same material composition and the same manufacturing process as the Predicate device.
| | GenesisZr® 4Y+ (ST1100)
Zirconia | ArgenZ HT+
Argen/K190079 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | GenesisZr® 4Y+ (ST1100) Zirconia
blanks are indicated for use by
dental technicians for the
production of full contour and
substructures restorations up to a
full arch. | ArgenZ HT+ (high translucent plus)
zirconia can be used for the
production of full contour
and substructures restorations up to
a full arch. |
| Contra- Indications | When GenesisZr® 4Y+ (ST1100)
Zirconia blanks are milled, the
dental technician should take
appropriate safety methods such
as face mask and eye protection
when removing the finished dental
prostheses from the holder to
preclude inhaling dust particles
upon removal with power tools.
• Insufficient tooth structure
reduction.1
• Insufficient tooth structure for
proper adhesion and force
distribution.1
• Insufficient oral hygiene.
• Insufficient interproximal space
for sufficient joints in bridges.1
• Known allergies.1
• Known incompatibilities to
product composition.1
• Heavy discoloration of prepped
tooth structure.1
1 as applicable to the finished article
installed by the dentist | There are no specific contra-
indications identified. |
| | GenesisZr® 4Y+ (ST1100)
Zirconia | ArgenZ HT+
Argen/K190079 |
| Material Composition
% wt. | Zirconia Powder:
ZrO2+HfO2+Y2O3: > 99 wt%
Inorganic Pigments 99 wt%
Inorganic Pigments 5.0 MPa m1/2 | Not supplied |
| Average Flexural
strength per ISO
6872:2015, Limit
800MPa | 1,100 MPa | 1,348 MPa |
| Chemical solubility
per ISO 6872:2015,
Limit 100 µg/cm2 | 8.229 µg/cm2 | 66.11 µg/cm2 |
| Biocompatibility per
ISO 10993-1: Part 1 -
'Biological evaluation
of medical devices -
Part 1: Evaluation
and testing within a
risk management
process. | | |
| | GenesisZr® 4Y+ (ST1100)
Zirconia | ArgenZ HT+
Argen/K190079 |
| 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, which is the same
manufacturing process used in
the industry to fabricate similar
devices. | Composition Material is acquired in
powder form. Argen HT+ is a
pressed Yttria stabilized Zirconia.
The raw materials and manufacturing
process used in the fabrication of
Argen HT+ are similar to the
materials and processes used in the
industry to fabricate the predicate
devices. |
| Safety and Efficacy of
the Device | 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. | Statement Not Supplied |
7
GenesisZr® 4Y+ (ST1100) ZIRCONIA 510(k) Premarket Submission
Image /page/7/Picture/1 description: The image shows a logo for United Dental Resources. The logo features the word "UNITED" in white, bold letters on a blue rectangular background. Below "UNITED" is the phrase "DENTAL RESOURCES" in smaller, white letters. The blue rectangle is set against a larger red shape, which appears to be a parallelogram tilted slightly to the right.
Section 5: 510(k) Summary
Page 17 of 84
8
GenesisZr® 4Y+ (ST1100) ZIRCONIA 510(k) Premarket Submission
Image /page/8/Picture/1 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" are the words "DENTAL RESOURCES" in a smaller, white, sans-serif font, also on the blue background. The blue rectangle is placed diagonally on a red background, which is also rectangular.
Section 5: 510(k) Summary
Page 18 of 84
10. Conclusion:
GenesisZr® 4Y+ (ST1100) Zirconia blank comparison to the predicate device, ArgenZ HT+ (K190079), 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. United Dental Resources has concluded that GenesisZr® 4Y+ (ST1100) Zirconia blanks are substantially equivalent to this legally marketed predicate device.