(230 days)
Luminesse Pre-Sintered Zirconia Coloring Liquid is a device that can be used as an accessory to zirconium dioxide dental restorative material such as Luminesse ZR blanks to provide individualized tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of all ceramic restorations for individual dental patients.
Luminesse® Pre-sintered Zirconia Coloring Liquid is a device that can be used as an accessory to zirconium dioxide dental restorative material such as Luminesse® ZR blanks to provide individualized tooth (or teeth) shading. It is a liquid ceramic aid for complete or partial coloring of all zirconium oxide blanks. Dental restorations are designed and manufactured by a certified dental professional (Technician) using CAD/CAM technology.
The provided document is a 510(k) Pre-Market Notification for a medical device called "Luminesse® Pre-Sintered Zirconia Coloring Liquid." This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a novel, high-risk device.
Therefore, the document does not contain a study that proves the device meets specific acceptance criteria in the traditional sense of a clinical or performance study for an AI/software device. Instead, it demonstrates substantial equivalence based on a comparison of technological characteristics and performance data that the new device shares with a predicate device.
Here's a breakdown of the requested information based on the provided document, highlighting where the information is not applicable due to the nature of a 510(k) substantial equivalence submission for this type of device:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a coloring liquid, the "acceptance criteria" are not framed as performance metrics for an AI or diagnostic device, but rather as characteristics of the material that show it is similar to the predicate. The performance data presented refers to standard physical and chemical properties.
| Characteristic | Acceptance Criteria (from predicate) | Reported Device Performance (Luminesse®) |
|---|---|---|
| Properties and Information | (Not framed as acceptance criteria, but as predicate characteristics for comparison) | (Not framed as acceptance criteria, but as subject device characteristics) |
| Acid-based/Water-based | Acid-based / Water-based | Acid-based / Water-based |
| Indication for Use | Liquid ceramic aid for complete or partial coloring of all zirconium oxide blanks intended to be used for all ceramic dental restorations | Liquid ceramic aid for complete or partial coloring of all zirconium oxide blanks intended to be used for all ceramic dental restorations |
| Prescription Use | Prescription only | Prescription only |
| Target Population | General, mostly adults | General, mostly adults |
| Type of Packaging | Liquid container | Liquid container |
| Method of Manufacture | Batch, at VITA® shade | Batch, at VITA® shade |
| Packaging Volume (mL) | 100 and 250 | 100 and 250 |
| VITA® Shade | 16 | 16 |
| Items in Product Line | 37 | 50 |
| Storage Conditions | 6 months at 4°C / 3-4 years at 4-10°C | 6 months at 4°C / 3-4 years at 4-10°C |
| General Physical Form | Liquid | Liquid |
| Specific Physical Form | Liquid | Liquid |
| Odor | Yellowish orange | Yellowish orange |
| Color | Mild Odor / Characteristic Odor | Characteristic odor / Yellowish orange |
| Physical and Chemical Properties | ||
| pH | 2 (Acid) / 7 (Water) | 1 - 1.5 (Acid) / 6.5-7.2 (Water) |
| Boiling Point | 100°C | 100°C |
| Density | 1.12 g/cm^3 (Acid) / 1.0 g/cm^3 (Water) | 1.03-1.09 g/cm^3 (Acid) / 1.05-1.10 g/cm^3 (Water) |
| Specific Gravity | 1.12 (Acid) / 1.0 (Water) | 1.03 - 1.09 (Acid) / 1.05-1.10 (Water) |
| Solubility, in Water | 100% | 100% |
| Sterility | Non-sterile | Non-sterile |
Conclusion from Document: The document concludes that "the differences…do not raise new questions of safety and effectiveness." The data supplied for both new and predicate device on physical and mechanical properties demonstrate similarity, "albeit unequal results," and are "within the expected specifications for zirconia dying liquid materials for dental application."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (N/A): This is a 510(k) submission for a coloring liquid, not a diagnostic or AI device that typically involves test sets of patient data. The "test set" here refers to the samples of the coloring liquid itself that were tested for physical and chemical properties. There is no mention of the specific number of liquid samples tested, nor is there information about data provenance in terms of country of origin or retrospective/prospective studies. The performance data is based on material property testing.
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)
- Not Applicable (N/A): Ground truth established by experts is relevant for diagnostic or AI systems where human interpretation is the gold standard. For a coloring liquid, the "ground truth" is determined by objective physical and chemical measurements (e.g., pH, density, boiling point), which are standard laboratory procedures, not expert consensus on qualitative data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in expert interpretation, typically in studies involving human readers or AI. This is not relevant for the objective physical and chemical testing of a dental coloring liquid.
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
- Not Applicable (N/A): MRMC studies are used to evaluate the performance of diagnostic tools (often AI-assisted) by comparing multiple readers on multiple cases. This device is a coloring liquid, not a diagnostic or AI tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A): This concept applies to standalone AI algorithms. The Luminesse® Pre-Sintered Zirconia Coloring Liquid is a physical material, not an algorithm. Its performance is inherent to its physical and chemical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Laboratory Measurements / Physical and Chemical Standards: The "ground truth" or reference for the device's characteristics are standardized measurements of physical properties (e.g., general physical form, specific physical form, odor, color, boiling point, density, specific gravity, solubility) and chemical properties (e.g., pH). These are determined in a laboratory setting using established analytical methods, not through expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
- Not Applicable (N/A): This device is a material, not a machine learning model. Therefore, there is no "training set" in the context of AI or data-driven model development.
9. How the ground truth for the training set was established
- Not Applicable (N/A): Since there is no training set as described above, this question is not applicable.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2015
Talladium, Inc. Ms. Elina Faskhutdinova RA/QA Manager 27360 W. Muirfield Lane Valencia, CA 91355
Re: K143090
Trade/Device Name: Luminesse® Pre-Sintered Zirconia Coloring Liquid Regulation Number: 21 CFR 872.660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: February 24, 2015 Received: March 17, 2015
Dear Ms. Faskhutdinova:
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. 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.
{1}------------------------------------------------
Page 2 - Ms. Elina Faskhutdinova
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K143090
Device Name
Luminesse Pre-Sintered Zirconia Coloring Liquid
Indications for Use (Describe)
Luminesse Pre-Sintered Zirconia Coloring Liquid is a device that can be used as an accessory to zirconium dioxide dental restorative material such as Luminesse ZR blanks to provide individualized tooth (or teeth) shading. It is intended to be used solely by certified dental techniciation of all ceramic restorations for individual dental patients.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
ك 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
{3}------------------------------------------------
"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."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740
{4}------------------------------------------------
Section 5– 510(k) SUMMARY
| Date: | 09 June 2015 |
|---|---|
| Sponsor: | Talladium's Inc. 27360 W. Muirfield LaneValencia, CA 91355P: (661) 295-0900 F: (661) 295-0895 |
| Contact Person: | Edward R. Harms |
| Trade Name: | Luminesse® Pre-sintered Zirconia Coloring Liquid |
| Common Name: | Powder, Porcelain |
| Device Classification: | Class II |
| Classification Number: | 872.6660 |
| Classification Panel: | Dental Devices |
| CDHR Product Code: | EIH |
| Device Description: | Luminesse® Pre-sintered Zirconia Coloring Liquid is a devicethat can be used as an accessory to zirconium dioxide dentalrestorative material such as Luminesse® ZR blanks to provideindividualized tooth (or teeth) shading. It is a liquid ceramic aid forcomplete or partial coloring of all zirconium oxide blanks. Dentalrestorations are designed and manufactured by a certified dentalprofessional (Technician) using CAD/CAM technology. |
| Intended Use: | The Luminesse® Pre-Sintered Zirconia Coloring Liquid isintended to be used by trained dental technicians or on the order ofa dental professional. The Luminesse® Pre-Sintered ZirconiaColoring Liquid is not for use by the general public or over-the-counter. |
| Indications for Use: | The Luminesse® Pre-Sintered Zirconia Coloring Liquid is adevice that can be used as an accessory to zirconium dioxide dentalrestorative material such as Luminesse ZR blanks to provideindividualized tooth (or teeth) shading. It is intended to beusedsolely by certified dental technicians for fabrication of all ceramicrestorations for individual dental patients. |
| Predicate Devices: | Upcera Coloring Liquid (I and II)K141723 |
| Performance Data: | The materials and fabrication processes used in the manufacture ofthe subject device are similar to the materials and fabricationprocesses used in the manufacture of the predicate device since themanufacturing of coloring liquids are widely similar in theindustry.Because material biocompatibility was accepted for the predicateand because there are no significant differences in manufacturingwhich could affect biocompatibility, additional biocompatibilitytesting was not supplied in support of this clearance. |
{5}------------------------------------------------
Data regarding performance testing was provided. Because similar material makeup is used for both the subject and predicate devices, these performance results support the finding of substantial equivalence. The results include general properties (physical form, odor, color), physical and chemical properties (pH, boiling point, density, specific gravity, solubility).
Technological Characteristics: The fundamental scientific technology of the Talladium's Luminesse® Pre-Sintered Zirconia Coloring Liquid is the same as the previously cleared device shown below, i.e., each of the design features is common to the predicate.
PREDICATE DEVICE CHART COMPARISON
| LUMINESSE® PRE-SINTEREDZIRCONIA COLORING LIQUID | Upcera Coloring Liquid (I and II) | ||||
|---|---|---|---|---|---|
| Properties andInformation | Acid-based | Water-based | Acid-based | Water-based | |
| 510(k) | K143090 | K141723 | |||
| Indication for Use | Liquid ceramic aid for complete or partialcoloring of all zirconium oxide blanksintended to be used for all ceramic dentalrestorations | Liquid ceramic aid for complete orpartial coloring of all zirconium oxideblanks intended to be used for allceramic dental restorations | |||
| Prescription Use | Prescription only | Prescription only | |||
| Target Population | General, mostly adults | General, mostly adults | |||
| Type of Packaging | Liquid container | Liquid container | Liquidcontainer | Liquidcontainer | |
| Method of Manufacture | Batch, at VITA® shade | Batch, at VITA® shade | |||
| Packaging Volume (mL) | 100 and 250 | 100 and 250 | 100 and 250 | ||
| VITA® Shade | 16 | 16 | 16 | ||
| Items in Product Line | 50 | 50 | 37 | ||
| Storage Conditions | 6 months at 4°C | 3-4 years at 4-10°C | 6 months at4°C | 3-4 years at 4-10°C | |
| General Physical Form: | Liquid | Liquid | Liquid | Liquid | |
| Specific Physical Form: | Liquid | Liquid | Liquid | Liquid | |
| Odor: | Yellowish orange | Yellowish orange | Yellowishorange | Yellowishorange | |
| Color: | Characteristic odor | Characteristicodor | Mild Odor | Characteristicodor |
{6}------------------------------------------------
Luminesse® Pre-sintered Zirconia Coloring Liquid 510(k) #: K143090
| pH: | 1 - 1.5 | 6.5-7.2 | 2 | 7 |
|---|---|---|---|---|
| Boiling Point: | 100°C | 100°C | 100°C | 100°C |
| Density: | 1.03-1.09 g/cm^3 | 1.05-1.10 g/cm^3 | 1.12 g/cm^3 | 1.0 g/cm^3 |
| Specific Gravity: | 1.03 - 1.09 | 1.05-1.10 | 1.12 | 1.0 |
| Solubility, in Water: | 100% | 100% | 100% | 100% |
| Sterility | Non-sterile | Non-sterile |
Conclusion: From the chart above, the differences between the subject device and the predicate device are primarily due to the available items in product lines and slight differences in density/specific gravity. Although the Luminesse® Pre-Sintered Zirconia Coloring Liquid and predicate devices are available in different volumes, shades and as water-based (both device under review and predicate) and acid-based (new device only), the differences of both the device and predicate device are not and does not raise new questions of safety and effectiveness of the device. Furthermore, the data supplied for both new and predicate device on physical and mechanical properties demonstrate similarity, albeit unequal results, and are within the expected specifications for zirconia dying liquid materials for dental application. Therefore, the differences observed in the chart above do not raise new questions.
In comparison to the predicate device, Luminesse® Pre-Sintered Zirconia Coloring Liquid has:
- The same intended use (as described above) and; -
- -Technological characteristics which do not raise new questions of safety and effectiveness.
In conclusion, Luminesse Pre-Sintered Zirconia Coloring Liquid is substantially equivalent to the predicate device, Upcera Coloring Liquid (I and II).
Edward R. Ham
Edward R. Harms (President/CEO)
June 9, 2015
§ 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.