(230 days)
Not Found
No
The document describes a coloring liquid for dental restorations and mentions CAD/CAM technology, but there is no mention of AI or ML in the intended use, device description, or any other section.
No.
The device is a coloring liquid for dental restorative material and is used by dental technicians to provide individualized tooth shading; it does not directly treat or diagnose a medical condition.
No
Explanation: The device is a coloring liquid for dental restorative materials to provide individualized tooth shading. It does not perform any diagnostic function such as identifying, detecting, or monitoring a disease or condition.
No
The device is a liquid coloring agent, which is a physical substance, 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 provide individualized tooth shading for dental restorations. This is a manufacturing process for a medical device (dental restoration), not a diagnostic test performed on a biological sample to determine a medical condition.
- Device Description: The device is described as a "liquid ceramic aid for complete or partial coloring of all zirconium oxide blanks." This further reinforces its role in the fabrication of dental restorations.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine 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
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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth (or teeth)
Indicated Patient Age Range
General, mostly adults
Intended User / Care Setting
certified dental technicians for fabrication of all ceramic restorations for individual dental patients.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The materials and fabrication processes used in the manufacture of the subject device are similar to the materials and fabrication processes used in the manufacture of the predicate device since the manufacturing of coloring liquids are widely similar in the industry. Because material biocompatibility was accepted for the predicate and because there are no significant differences in manufacturing which could affect biocompatibility, additional biocompatibility testing was not supplied in support of this clearance.
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Upcera Coloring Liquid (I and II)K141723
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/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.
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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
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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 Lane |
| Valencia, CA 91355 | |
| P: (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 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. | |
| Intended Use: | The Luminesse® Pre-Sintered Zirconia Coloring Liquid is |
| intended to be used by trained dental technicians or on the order of | |
| a dental professional. The Luminesse® Pre-Sintered Zirconia | |
| Coloring Liquid is not for use by the general public or over-the- | |
| counter. | |
| Indications for Use: | The 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 beused | |
| solely by certified dental technicians for fabrication of all ceramic | |
| restorations for individual dental patients. | |
| Predicate Devices: | Upcera Coloring Liquid (I and II)K141723 |
| Performance Data: | The materials and fabrication processes used in the manufacture of |
| the subject device are similar to the materials and fabrication | |
| processes used in the manufacture of the predicate device since the | |
| manufacturing of coloring liquids are widely similar in the | |
| industry. | |
| Because material biocompatibility was accepted for the predicate | |
| and because there are no significant differences in manufacturing | |
| which could affect biocompatibility, additional biocompatibility | |
| testing 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-SINTERED
ZIRCONIA COLORING LIQUID | | Upcera Coloring Liquid (I and II) | | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--|
| Properties and
Information | Acid-based | Water-based | Acid-based | Water-based | |
| 510(k) | K143090 | | K141723 | | |
| 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 | Liquid
container | Liquid
container | |
| 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 at
4°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 | Yellowish
orange | Yellowish
orange | |
| Color: | Characteristic odor | Characteristic
odor | Mild Odor | Characteristic
odor | |
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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