LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID

K143090 · Talladium, Inc. · EIH · Jun 15, 2015 · Dental

Device Facts

• Record ID: K143090
• Device Name: LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID
• Applicant: Talladium, Inc.
• Product Code: EIH · Dental
• Decision Date: Jun 15, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

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.

Device Story

Luminesse Pre-Sintered Zirconia Coloring Liquid is a liquid ceramic aid used by certified dental technicians to color zirconium oxide blanks prior to sintering. The device is applied to CAD/CAM-manufactured zirconia restorations to achieve individualized tooth shading. It is available in acid-based and water-based formulations. The technician applies the liquid to the pre-sintered zirconia blank; the coloring agent penetrates the material to provide the desired aesthetic shade. This process allows for the creation of customized, natural-looking all-ceramic dental restorations. The device is used in a dental laboratory setting. By enabling precise shade matching, the liquid improves the aesthetic outcome of the final dental restoration for the patient.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included physical and chemical property characterization (pH, boiling point, density, specific gravity, solubility) and comparison of general properties (physical form, odor, color) against the predicate device. Biocompatibility was accepted based on the similarity of materials and manufacturing processes to the predicate.

Technological Characteristics

Liquid ceramic coloring agent for pre-sintered zirconia. Formulations: acid-based and water-based. Physical properties: pH 1-1.5 (acid-based) or 6.5-7.2 (water-based); boiling point 100°C; density 1.03-1.10 g/cm³. Non-sterile. Packaged in liquid containers (100 mL and 250 mL).

Indications for Use

Indicated for use as an accessory to zirconium dioxide dental restorative material (e.g., Luminesse ZR blanks) to provide individualized tooth shading. Intended solely for use by certified dental technicians for the fabrication of all-ceramic restorations for individual dental patients.

Regulatory Classification

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.

Predicate Devices

• Upcera Coloring Liquid (I and II) (K141723)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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# Section 5– 510(k) SUMMARY

| Date: | 09 June 2015 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Talladium's Inc. 27360 W. Muirfield Lane<br>Valencia, CA 91355<br>P: [phone] F: [phone] |
| 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<br>that can be used as an accessory to zirconium dioxide dental<br>restorative material such as Luminesse® ZR blanks to provide<br>individualized tooth (or teeth) shading. It is a liquid ceramic aid for<br>complete or partial coloring of all zirconium oxide blanks. Dental<br>restorations are designed and manufactured by a certified dental<br>professional (Technician) using CAD/CAM technology. |
| Intended Use: | The Luminesse® Pre-Sintered Zirconia Coloring Liquid is<br>intended to be used by trained dental technicians or on the order of<br>a dental professional. The Luminesse® Pre-Sintered Zirconia<br>Coloring Liquid is not for use by the general public or over-the-<br>counter. |
| Indications for Use: | The Luminesse® Pre-Sintered Zirconia Coloring Liquid is a<br>device that can be used as an accessory to zirconium dioxide dental<br>restorative material such as Luminesse ZR blanks to provide<br>individualized tooth (or teeth) shading. It is intended to beused<br>solely by certified dental technicians for fabrication of all ceramic<br>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<br>the subject device are similar to the materials and fabrication<br>processes used in the manufacture of the predicate device since the<br>manufacturing of coloring liquids are widely similar in the<br>industry.<br>Because material biocompatibility was accepted for the predicate<br>and because there are no significant differences in manufacturing<br>which could affect biocompatibility, additional biocompatibility<br>testing was not supplied in support of this clearance. |

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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<br>ZIRCONIA COLORING LIQUID | | Upcera Coloring Liquid (I and II) | | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--|
| Properties and<br>Information | Acid-based | Water-based | Acid-based | Water-based | |
| 510(k) | K143090 | | K141723 | | |
| Indication for Use | Liquid ceramic aid for complete or partial<br>coloring of all zirconium oxide blanks<br>intended to be used for all ceramic dental<br>restorations | | Liquid ceramic aid for complete or<br>partial coloring of all zirconium oxide<br>blanks intended to be used for all<br>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<br>container | Liquid<br>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-<br>10°C | 6 months at<br>4°C | 3-4 years at 4-<br>10°C | |
| General Physical Form: | Liquid | Liquid | Liquid | Liquid | |
| Specific Physical Form: | Liquid | Liquid | Liquid | Liquid | |
| Odor: | Yellowish orange | Yellowish orange | Yellowish<br>orange | Yellowish<br>orange | |
| Color: | Characteristic odor | Characteristic<br>odor | Mild Odor | Characteristic<br>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