(174 days)
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No
The description focuses on the material properties and manufacturing process (CAD/CAM milling and sintering) of zirconia blanks for dental prosthetics. There is no mention of AI or ML being used in the design, manufacturing, or application of the device.
No
The device is a material (zirconia blanks) used to create prosthetic dental restorations (dentures, crowns, bridges), which replace missing or damaged teeth. While these prostheses improve function and aesthetics, the blanks themselves do not directly treat a disease or condition. They are components that are manufactured into devices that restore anatomical structures.
No
This device is a material (zirconia blanks) used to create dental prostheses (dentures, crowns, and bridges). Its function is to be milled and sintered into a custom shape, not to diagnose medical conditions.
No
The device is a physical zirconia blank used for creating dental prostheses, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create dental prostheses (dentures, crowns, and bridges) for prosthetic dentistry. This is a restorative and structural application, not a diagnostic one.
- Device Description: The device is a material (zirconia blanks) that is further processed (milled, sintered, colored) to create a custom dental restoration. It does not perform any tests on biological samples to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It is a material used in the treatment of missing or damaged teeth.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
EthanZir™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures. crowns and bridges). EthanZir™ Zirconia blanks are intended to be milled and fully sintered by a Dental Professional or Dental Laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions. Substructure ceramic for prostheses involving four or more units can be created.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
EthanZir™ Zirconia are disc 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 dentures, crowns or bridges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing: Besorah Dental Solutions 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 quidance 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. EthanZir™ 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)".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Glidewell Prismatik™ Clinical Zirconia (Prismatik™ CZ), (K060104)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image contains 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 logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
November 4, 2019
Besorah Dental Solutions NZ Limited % Robin Carden President / CEO RAC Corporation 27134 Paseo Espada San Juan Capistrano, California 92675
Re: K191304
Trade/Device Name: EthanZir Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH Dated: August 5, 2019 Received: August 7, 2019
Dear Robin 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. 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
1
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 (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 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,
Srinivas Nandkumar, Ph.D. Acting 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
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Image /page/2/Picture/1 description: The image shows the logo for Besorah Dental Solutions NZ Limited. The logo features a stylized fern frond next to the company name. Below the logo, the text "Section 4: Indications for Use Statement" is displayed in a larger font size.
| 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) K191304
Device Name EthanZirTM Zirconia
Indications for Use (Describe)
EthanZirM Ziconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures. crowns and bridges). EthanZirM Zirconia blanks are intended to be milled and fully sintered by a Dental Professional or Dental Laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions. Substructure ceramic for prostheses involving four or more units can be created.
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
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
17/9 Chonny Crescent, Manurewa, Auckland, New Zealand -2102 Phone: +64211268337
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Image /page/3/Picture/1 description: The image shows a stylized logo. The logo features a fern frond on the left side, with its leaflets clearly defined. To the right of the fern is a curved shape resembling a letter 'D' or a crescent moon. The fern and the curved shape are both in black, creating a simple yet distinctive design.
K191304
510(k) Summary
for
BESORAH DENTAL SOLUTIONS NZ, LTD
EthanZir™ Zirconia
1. Submitter
BESORAH DENTAL SOLUTIONS NZ LIMITED
17/9 Chonny Crescent, Manurewa, Auckland, New Zealand, 2102
Phone: +64211268337
Device Name 2.
Proprietary Name: EthanZir™ Zirconia Common/Usual Name: Powder, Porcelain Porcelain powder for clinical use Classification Name: K191304/S001 Prior submission #:
3. Predicate Devices
Glidewell Prismatik™ Clinical Zirconia (Prismatik™ CZ), (K060104)
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Image /page/4/Picture/1 description: The image shows a black and white logo. The logo features a fern leaf on the left side and a crescent shape on the right side. The fern leaf is depicted with its characteristic fronds, and the crescent shape is positioned to partially encircle the fern leaf.
4. A. Indications for Use
EthanZir™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). EthanZir™ Zirconia blanks are intended to be milled and fully sintered by a Dental Professional or Dental Laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions. Substructure ceramic for prostheses involving four or more units can be created.
B. Classification regulation 21 CFR 872.6660, Class II, product code EIH
5. Device Description and Function
EthanZir™ Zirconia are disc 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 dentures, crowns or bridges.
6. Physical and Performance Characteristics
Design:
CAD CAM design
Material Used:
EthanZir™ 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".
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Image /page/5/Picture/1 description: The image shows a logo with two distinct elements. On the left, there is a stylized fern frond, depicted in black with a series of parallel lines forming the leaflets. To the right of the fern, there is a large, curved shape resembling a crescent or a partial letter 'D', also in black. The two elements are positioned close together, creating a unified design.
Physical Properties:
Tabulated chart of finished product "EthanZir™ 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:
7. Nonclinical Testing
Besorah Dental Solutions 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 quidance 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. EthanZir™ 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)".
8. Clinical Testing
Clinical tests have not been performed.
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Image /page/6/Picture/1 description: The image shows a logo that combines a stylized fern frond with a letter 'D'. The fern frond is on the left side of the image and is depicted with a series of small, pointed leaves extending from a central stem. The letter 'D' is on the right side of the image and is a bold, curved shape that partially encloses the fern frond. The logo is simple, modern, and nature-inspired.
- Conclusion: EthanZir™ Zirconia blank comparison to the predicate device 9. Glidewell Prismatik™ Clinical Zirconia (Prismatik™ CZ K060104) and 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, Besorah Dental Solutions believes that EthanZir™ Zirconia blanks are substantially equivalent to these legally marketed predicate devices.