(59 days)
Not Found
No
The summary describes a ceramic slurry for 3D printing dental restorations and does not mention any AI or ML components in its description, intended use, or performance studies.
No.
The device is a ceramic slurry used to fabricate dental restorations; it is not directly applied to or used on a patient for a therapeutic purpose.
No
The UltraThineer Zirconia Slurry is used for the construction/fabrication of ceramic restorations, not for diagnosing conditions.
No
The device is a physical ceramic slurry intended for use in 3D printing and sintering processes to create dental restorations. It is a material, 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 for dental technicians to construct custom-made ceramic restorations (copings, crowns, etc.). This is a manufacturing process for a medical device that will be used in the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a ceramic slurry used in a 3D printing and sintering process to create dental restorations. This is a material used in fabrication, not a reagent or instrument for performing a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
EIH
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.
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 technicians
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)
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.
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.
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.
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)
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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 Predicate
Device | A - Well
established
methods | B - Meets or
exceeds
expected
predicate
performance | C - Unmitigated
use-related or
design-related
safety issues | D - Associated
design-related
recall |
|---------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------|
| Inni-Cera | Used relevant
methods that
were published
in the public
domain. | History of Safe
use, established
due to duration
of device on the
market | No known
unmitigated use-
related or design
related safety
issues | No design-
related recall
identified |
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 872.6660 | |
| Porcelain powder for clinical use | 21 CFR 872.6660 | |
| Porcelain powder for clinical use | ||
| Classification | II | II |
| Device | ||
| Description: | UltraThineer Zirconia Slurry device is | |
| intended for use in fabricating custom- | ||
| made ceramic restorations using a 3D | ||
| printer additive manufacturing | ||
| process. There is one formulation, | INNI-CERA is intended for use in | |
| fabricating custom-made ceramic | ||
| restorations using a 3D printer additive | ||
| manufacturing process. It is a product | ||
| that is used after fabricating and | ||
| Contents | Subject Device | Predicate Device |
| BMF-5YZ-1.6B. It is a product that is | ||
| used after fabricating and sintering | ||
| with a mixture of zirconia powder and | ||
| binder. The 3D printer used to | ||
| fabricate the UltraThineer Zirconia | ||
| Slurry is a photocuring lamination | ||
| method using an STL file (dental | ||
| restoration shape), which is irradiated | ||
| with light in the strong UV region | ||
| (420nm) to cure the photocurable | ||
| mixture to form a model. This product | ||
| corresponds to ISO 6872 Type I Class | ||
| III. The material is used in a 3D printer, | ||
| which prints the shape determined by | ||
| an STL file converted from patients' | ||
| teeth data. The 3D printer is not | ||
| included with the product. The | ||
| UltraThineer Zirconia Slurry device | ||
| cannot be reused. | sintering with a mixture of zirconia | |
| powder and binder. The DLP 3D | ||
| printer used to fabricate the INNI- | ||
| CERA is a photocuring lamination | ||
| method using an STL file (dental | ||
| restoration shape), which is irradiated | ||
| with light in the strong UV region | ||
| (420nm) to cure the photocurable | ||
| mixture to form a model. This product | ||
| corresponds to ISO 6872 Type I Class | ||
| III. The material is used in a 3D | ||
| printer, which prints the shape | ||
| determined by an STL file converted | ||
| from patients' teeth data. 3D printer is | ||
| not included with the product. INNI- | ||
| CERA cannot be reused. | ||
| 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). | INNI-CERA is indicated for use by | |
| dental technicians in the construction | ||
| of custom-made ceramic restorations. | ||
| Coping | ||
| Crown | ||
| Inlay & Onlay | ||
| Veneer | ||
| Bridge (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 or | ||
| Reusable: | 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 Thermal | ||
| Expansion | ||
| Coefficient | Mean linear thermal expansion | |
| coefficient within 0.5 x 10-6 K-1 of the | ||
| value reported by the manufacturer | Unknown | |
| Contents | Subject Device | Predicate Device |
| (meeting ISO 6872 requirements) | (meeting ISO 6872 requirements) | |
| Chemical Solubility |