Who is the manufacturer of GenesisZr UHT700 Zirconia?

United Dental Resources Corporation filed the 510(k) submission for GenesisZr UHT700 Zirconia (K201608).

What is the FDA product code for GenesisZr UHT700 Zirconia?

EIH. It is classified under 21 CFR 872.6660 as a Class 2 device in the Dental panel.

What is the regulatory pathway for GenesisZr UHT700 Zirconia?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like GenesisZr UHT700 Zirconia?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GenesisZr UHT700 Zirconia

K201608 · United Dental Resources Corporation · EIH · Jan 28, 2021 · Dental

Device Facts

Record ID	K201608
Device Name	GenesisZr UHT700 Zirconia
Applicant	United Dental Resources Corporation
Product Code	EIH · Dental
Decision Date	Jan 28, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.6660
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

GenesisZr UHT700 Zirconia are yttria-stabilized tetragonal zirconia (Y-TZP) ceramic blanks (discs/blocks) used by dental laboratories to fabricate custom dental restorations. Dental offices provide anatomical renderings; laboratories use CAD/CAM systems to mill blanks into crowns or substructures. Milled restorations are sintered and colored before fitting to patient teeth. Device provides biocompatible, high-strength ceramic material for restorative dentistry. Benefits include custom-fit, durable prosthetic solutions for anterior/posterior applications.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including density, bending strength, fracture toughness, chemical solubility, and material characterization per ISO 6872:2015 and ISO 13356:2015.

Technological Characteristics

Yttria-stabilized tetragonal zirconia (Y-TZP) ceramic. Sintered density ≥ 6.04 g/cm3; flexural strength > 600 MPa; fracture toughness 2.4 MPa m0.5; CTE 10.2 µm/m °C. Complies with ISO 6872:2015 and ISO 13356:2015. Form factor: disc/block blanks for CAD/CAM milling.

Indications for Use

Indicated for single-unit anterior or posterior prostheses and three-unit prostheses (excluding molar restoration) as monolithic-ceramic or fully covered substructures. Contraindicated for restorations >3 units and 3-unit prostheses involving molars.

Regulatory Classification

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.

Predicate Devices

Pavati® Z40.2 (K160867)

Related Devices

K191304 — EthanZir Zirconia · Besorah Dental Solutions NZ Limited · Nov 4, 2019
K201915 — GenesisZr 4Y+ (ST1100) Zirconia · United Dental Resources Corporation · Feb 23, 2021
K250393 — ZircaGlow & ZircaGlow HT Zirconia · United Zirconia · May 12, 2025
K160867 — Pavati Z40.2 Zirconia · Ccri, Inc. · Sep 12, 2016
K212259 — Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank · Zirdent New Material Co., Ltd. · Nov 12, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ 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. 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." {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: K201608 ## 510(k) Summary for ## United Dental Resources Corporation ## GenesisZr® UHT700 Zirconia 1. 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 | < 100 µg/cm2 | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for United Dental Resources. The logo features the word "UNITED" in blue, stacked above the words "DENTAL RESOURCES" in a smaller font. The text is set against a red, white, and blue background, with the red portion appearing as a diagonal stripe behind the blue text. ### 7. Nonclinical Testing 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)". #### 8. Clinical Testing Clinical tests have not been performed. #### 9. Substantial Equivalence Discussion GenesisZr® UHT700 Zirconia blank comparison to the predicate device, CCRI, Inc., Pavati® Z40.2 (K160867), 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. GenesisZr® UHT700 Zirconia utilizes an identical composition which results in an identical flexural strength of >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 | <0.03 | Meets ISO Standard | | Sintered Density g/cm3 ISO 13356: 2015 Section 4.1 Req't. of ≥ 6.0 | 6.04 g/cm3 | ≥ 6.00 g /cm3 | | Coefficient of thermal expansion (CTE) | 10.2 µm/m °C | 10.3 µm/m °C | | Fracture toughness Kic | 2.4 MPa m0.5 | >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 | < 100 µg/cm2 | | 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 the exact same materials and manufacturing methods as legally marketed predicate devices | Biocompatible and Non-toxic Assured through use of same materials and manufacturing methods as legally marketed predicate devices. | | Blank sizes(mm) | Disc: 95-110mm x 10-30mm | Block: 65-85 x 40 x 15 20-55 x 19 x 15 40 x 15 x 15 14 x 13 x 15 18 x 14.5 x 12.4 Near net shapes Disc: 95-110 x 12-30 | {7}------------------------------------------------ GenesisZr® UHT700 ZIRCONIA 510(k) Premarket Submission Image /page/7/Picture/1 description: The image shows the logo for United Dental Resources. The logo features the word "UNITED" in large, bold, white letters on a blue rectangular background. Below "UNITED" are the words "DENTAL RESOURCES" in smaller, white letters. The blue rectangle is set against a red, triangular background, giving the logo a dynamic and eye-catching appearance. Section 5: 510(k) Summary Page 16 of 80 {8}------------------------------------------------ Image /page/8/Picture/4 description: The image shows the logo for United Dental Resources. The logo features the word "UNITED" in white, sans-serif font on a blue rectangle. Below "UNITED" are the words "DENTAL RESOURCES" in a smaller, white, sans-serif font. The blue rectangle is placed on top of a red parallelogram, which is slightly rotated. #### 10. Conclusion: GenesisZr® UHT700 Zirconia blank comparison to the predicate device, CCRI, Inc., Pavati® Z40.2 (K160867), 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. As such, United Dental Resources has concluded that GenesisZr® UHT700 Zirconia blanks are substantially equivalent to this legally marketed predicate device.