(59 days)
UltraThineer Zirconia Slurry is indicated for use by dental technicians in the construction of custommade ceramic restorations. These include copings, crowns, inlays and onlays, veneers, and bridges (3-unit anterior bridges).
The UltraThineer Zirconia Slurry is a ceramic slurry intended for use in fabricating custom-made ceramic restorations using 3D printing and sintering processes. There is a single formulation: Zirconia-5Y/BMF-5YZ-1.6B. The UltraThineer Zirconia Slurry is provided as a slurry contained in a sealed tamper-proof and opaque HDPE bottle, with product labeling. The bottle containing the slurry has dimensions of 3.5" in diameter and 7.75" in height and has a maximum volume of 0.75L. For use, the slurry is poured into a vat inside the 3D printer for printing the dental veneer. After printing, the veneer is sintered to yield the final product. Each veneer will be custom fabricated on a named patient prescription basis on the order of a dentist.
The provided text describes a 510(k) premarket notification for a medical device called "UltraThineer Zirconia Slurry (5Y-B)". This document primarily focuses on demonstrating substantial equivalence to a predicate device, not on presenting a study proving the device meets specific acceptance criteria in the manner of a clinical trial for an AI/software device.
Therefore, many of the requested details about acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, and standalone performance are not applicable to this type of regulatory submission because it is for a material (zirconia slurry) and not an AI/software device.
However, I can extract the relevant "acceptance criteria" (performance parameters) and "reported device performance" from the Non-Clinical Performance Data (Bench Testing) and Biocompatibility Testing sections as the "study" that proves the device meets these criteria.
Here's the breakdown of the information that can be extracted, and where the information is absent or not relevant for this type of submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Parameter) | Reported Device Performance (UltraThineer Zirconia Slurry) |
|---|---|
| Biocompatibility (ISO 10993-1) | Met biocompatibility requirements (Chemical Characterization, Cytotoxicity, Sensitization, Oral Mucosal Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity) |
| Radioactivity (ISO 6872:2015) | Activity concentration of uranium238 less than 1.0 Bqg-1 (meeting ISO 6872 requirements) |
| Flexural Strength (ISO 6872:2015) | >300 Mpa (meeting ISO 6872 requirements) |
| Linear Thermal Expansion Coefficient (ISO 6872:2015) | Mean linear thermal expansion coefficient within 0.5 x 10^-6 K^-1 of the value reported by the manufacturer (meeting ISO 6872 requirements) |
| Chemical Solubility (ISO 6872:2015) | < 100 µg/cm² (meeting ISO 6872 requirements) |
| Shelf-Life Testing | Met the requirements of the standard |
| ISO 6872 Type/Classification | Type 1 / Class 3 |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document as it's a 510(k) summary for a material, not a clinical study or AI/software validation. The bench testing involved physical and chemical property measurements on samples of the zirconia slurry.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable. Ground truth, in the context of expert consensus, is typically relevant for interpretative devices (like AI for image analysis). For material testing, "ground truth" is defined by the objective measurement according to established international standards (like ISO 6872 and ISO 10993-1).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used in clinical trials or expert review processes, which are not detailed for the material property testing described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This type of study is specifically for AI-enabled diagnostic or assistive software, not for dental materials.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This term refers to the performance of an AI algorithm directly, which does not apply to a physical dental material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance criteria for this device (a material) is based on International Standards such as ISO 6872:2015 for ceramic materials and ISO 10993-1 for biological evaluation of medical devices. The device's properties were measured and compared against the defined thresholds and methodologies within these standards.
8. The sample size for the training set
This is not applicable. The concept of a "training set" is relevant for machine learning/AI algorithms that learn from data. This document describes a physical material, not an AI system.
9. How the ground truth for the training set was established
This is not applicable for the reason stated in point 8.
{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 the FDA logo, which 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.
April 12, 2024
Boston Micro Fabrication % Eric Bannon Sr. VP, Regulatory and Clinical Affairs AlvaMed 935 Great Plain Ave Suite 166 Needham, Massachusetts 02942
Re: K240419
Trade/Device Name: UltraThineer Zirconia Slurry (5Y-B) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: February 12, 2024 Received: February 13, 2024
Dear Eric Bannon:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
{1}------------------------------------------------
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices
{2}------------------------------------------------
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
Submission Number (if known)
Device Name
UltraThineer Zirconia Slurry (5Y-B)
Indications for Use (Describe)
UltraThineer Zirconia Slurry is indicated for use by dental technicians in the construction of custommade ceramic restorations. These include copings, crowns, inlays and onlays, veneers, and bridges (3-unit anterior bridges).
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."
{4}------------------------------------------------
K240419
510(K) SUMMARY
Name and Address of Submitter
BMF Precision, Inc. 8 Mill & Main St., Suite 310 Maynard, MA 01754 USA Phone: +1 978-637-2050 John Kawola CEO jkawola@bmf3d.com Phone: +1 781-492-3548
Correspondent/Primary Contact Person
Eric Bannon Vice President of Requlatory and Clinical Affairs AlvaMed, Inc. ebannon@alvamed.com Phone: +1 (781) 710-8243 Fax: +1 (617) 249-0955
Submission Information
Date Summary Prepared: Name of Device: Device Classification Name: Common or Usual Name: Classification: Product Code:
27 January 2023 UltraThineer Zirconia Slurry (5Y-B) Porcelain Powder for Clinical Use Dental Zirconia Material Class II EIH (21 CFR 872.6660)
Device Description
The UltraThineer Zirconia Slurry is a ceramic slurry intended for use in fabricating custom-made ceramic restorations using 3D printing and sintering processes.
There is a single formulation:
- Zirconia-5Y/BMF-5YZ-1.6B .
The UltraThineer Zirconia Slurry is provided as a slurry contained in a sealed tamper-proof and opaque HDPE bottle, with product labeling. The bottle containing the slurry has dimensions of 3.5" in diameter and 7.75" in height and has a maximum volume of 0.75L.
For use, the slurry is poured into a vat inside the 3D printer for printing the dental veneer. After printing, the veneer is sintered to yield the final product. Each veneer will be custom fabricated on a named patient prescription basis on the order of a dentist.
Predicate Device
INNI-CERA by Aon Co., Ltd (K211308)
{5}------------------------------------------------
Valid Predicate Discussion
Inni-Cera was selected as the valid predicate device used to support the 510(k) submission because it was cleared using well-established methods. Inni-Cera was the only valid predicate device that could be identified which meets the expected predicate performance. After conducting a search on the Manufacturer and User Facility Device Experience (MAUDE) Database, Medical Device Reporting (MDR), MedSun Reports Database, Medical Device Safety and CBER Safety & Availability (Biologics) and Recall Database websites it was found that there are no known unmitigated use-related or design safety issues and the predicate device has not been subject to a design-related recall.
Table 1: Valid Predicate Device
| Valid PredicateDevice | A - Wellestablishedmethods | B - Meets orexceedsexpectedpredicateperformance | C - Unmitigateduse-related ordesign-relatedsafety issues | D - Associateddesign-relatedrecall |
|---|---|---|---|---|
| Inni-Cera | Used relevantmethods thatwere publishedin the publicdomain. | History of Safeuse, establisheddue to durationof device on themarket | No knownunmitigated use-related or designrelated safetyissues | No design-related recallidentified |
Indications for Use
UltraThineer Zirconia Slurry is indicated for use by dental technicians in the construction of custom-made ceramic restorations. These include copings, crowns, inlays and onlays, veneers, and bridges (3-unit anterior bridges).
Table 2: Comparison of Predicate Device and Subject Device
| Contents | Subject Device | Predicate Device |
|---|---|---|
| Device: | UltraThineer Zirconia Slurry (5Y-B) | INNI-CERA |
| Manufacturer: | Boston Micro Fabrication | Aon Co., Ltd |
| 510(k) Number: | Pending | K211308 |
| Product Code(s): | EIH | EIH |
| Regulation Number& Description: | 21 CFR 872.6660Porcelain powder for clinical use | 21 CFR 872.6660Porcelain powder for clinical use |
| Classification | II | II |
| DeviceDescription: | UltraThineer Zirconia Slurry device isintended for use in fabricating custom-made ceramic restorations using a 3Dprinter additive manufacturingprocess. There is one formulation, | INNI-CERA is intended for use infabricating custom-made ceramicrestorations using a 3D printer additivemanufacturing process. It is a productthat is used after fabricating and |
| Contents | Subject Device | Predicate Device |
| BMF-5YZ-1.6B. It is a product that isused after fabricating and sinteringwith a mixture of zirconia powder andbinder. The 3D printer used tofabricate the UltraThineer ZirconiaSlurry is a photocuring laminationmethod using an STL file (dentalrestoration shape), which is irradiatedwith light in the strong UV region(420nm) to cure the photocurablemixture to form a model. This productcorresponds to ISO 6872 Type I ClassIII. The material is used in a 3D printer,which prints the shape determined byan STL file converted from patients'teeth data. The 3D printer is notincluded with the product. TheUltraThineer Zirconia Slurry devicecannot be reused. | sintering with a mixture of zirconiapowder and binder. The DLP 3Dprinter used to fabricate the INNI-CERA is a photocuring laminationmethod using an STL file (dentalrestoration shape), which is irradiatedwith light in the strong UV region(420nm) to cure the photocurablemixture to form a model. This productcorresponds to ISO 6872 Type I ClassIII. The material is used in a 3Dprinter, which prints the shapedetermined by an STL file convertedfrom patients' teeth data. 3D printer isnot included with the product. INNI-CERA cannot be reused. | |
| Indications ForUse | UltraThineer Zirconia Slurry isindicated for use by dental techniciansin the construction of custom-madeceramic restorations. These includecopings, crowns, inlays and onlays,veneers, and bridges (3-unit anteriorbridges). | INNI-CERA is indicated for use bydental technicians in the constructionof custom-made ceramic restorations.CopingCrownInlay & OnlayVeneerBridge (3-unit anterior bridges) |
| ISO 6872 Type/Classification: | Type 1/Class 3 | Type 1/Class 3 |
| Material Type | Slurry | Slurry |
| Provided Sterile: | Non-Sterile | Non-Sterile |
| Single-Use orReusable: | Single Use | Single Use |
| Biocompatibility | According to EN ISO 10993-1 | According to EN ISO 10993-1 |
| Flexural Strength | >300 Mpa(meeting ISO 6872 requirements) | >300 Mpa(meeting ISO 6872 requirements) |
| Linear ThermalExpansionCoefficient | Mean linear thermal expansioncoefficient within 0.5 x 10-6 K-1 of thevalue reported by the manufacturer | Unknown |
| Contents | Subject Device | Predicate Device |
| (meeting ISO 6872 requirements) | (meeting ISO 6872 requirements) | |
| Chemical Solubility | < 100µg/cm² | < 100µg/cm² |
| (meeting ISO 6872 requirements) | (meeting ISO 6872 requirements) | |
| Radioactivity | Activity concentration of uranium238 less than 1.0Bqg-1(meeting ISO 6872 requirements) | Activity concentration of uranium238 less than 1.0Bqg-1(meeting ISO 6872 requirements) |
| Production Type | 3D Printing | 3D Printing |
{6}------------------------------------------------
{7}------------------------------------------------
Summary of Substantial Equivalence Comparison to the Predicate Device
The information provided for the subject device Indication for Use, Material, Biocompatibility, Flexural Strength, Linear Thermal Expansion Coefficient, Chemical Solubility and Radioactivity are equivalent to the predicate device, Inni-Cera cleared under K 211308. Both are zirconia slurry materials intended for 3D printing of dental implants followed by sintering. Both devices are composed of biocompatible material according to ISO 10993-1 and meet the requirements of ISO 6872. Both devices are intended for use by dental technicians in the construction of custom-made ceramic restorations.
Biocompatibility Testing
UltraThineer Zirconia Slurry (5Y-B) was evaluated according to ISO 10993-1. The results of these tests confirmed that it met the biocompatibility requirements. Biocompatibility testing included:
- Chemical Characterization .
- Cytotoxicity
- Sensitization ●
- Oral Mucosal Irritation ●
- Acute Systemic Toxicity ●
- . Material Mediated Pyrogenicity
Non-Clinical Performance Data: Bench
The UltraThineer ceramic materials were evaluated according to ISO 6872:2015. The results of those test confirmed that the UltraThineer met all requirements of the standard. Testing included: Radioactivity; Flexural Strength; Linear Thermal Expansion Coefficient; Chemical Solubility; and; Shelf-Life Testing.
Performance Data: Clinical Testing
No clinical testing was applicable to this submission.
{8}------------------------------------------------
Conclusions
Like the predicate device originally cleared by the FDA. UltraThineer Zirconia Slurry has been shown to be safe through Bench Testing and Biocompatibility testing according to the above mentioned ISO standards. The data support substantial equivalence of the UltraThineer Zirconia Slurry subject device to the legally marketed predicate device.
The performance of the UltraThineer Zirconia Slurry meets the requirements of the non-clinical bench testing conducted to support substantial equivalence. Based on the available information, the subject device and the predicates are similar indication for use, material, performance data and biocompatibility.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification that it can be concluded that the subject device is substantially equivalent with predicate device.
§ 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.