LUMINESSE PORCELAIN SYSTEM

K140848 · Talladium, Inc. · EIH · Dec 17, 2014 · Dental

Device Facts

• Record ID: K140848
• Device Name: LUMINESSE PORCELAIN SYSTEM
• Applicant: Talladium, Inc.
• Product Code: EIH · Dental
• Decision Date: Dec 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

The Luminesse Porcelain is intended to be used by trained dental technicians or on the order of a dental professional. The Luminesse Porcelain is not for use by the general public or over the-counter.

Device Story

Luminesse Porcelain System comprises dental porcelain materials (low fusing, high fusing, zirconia) used by dental technicians to fabricate biocompatible crowns, bridges, and veneers. System includes pressable ingots, powders (opaque, dentin, incisal, modifiers, correction, glaze), and liquids. Technician applies porcelain to metal, zirconia, or pressable ceramic frameworks; material is fired to fuse to the base. Coefficient of thermal expansion (CTE) is adjusted to match base materials to prevent cracking and stress-induced damage. Final output is a custom dental prosthetic. Used in dental laboratories; operated by trained technicians on prescription from dental professionals. Benefits include restoration of dental function and esthetics.

Clinical Evidence

Bench testing only. Testing conducted in accordance with ISO 6872 to determine flexural strength, solubility, and glass transition temperature. No clinical data provided.

Technological Characteristics

Leucite-fortified glass ceramic and feldspathic porcelain. Provided in powder, liquid, paste, and pressable pellet formats. CTE adjusted to match base materials (metal or zirconia). Bench testing per ISO 6872. No software or electronic components.

Indications for Use

Indicated for use in conjunction with metal, zirconia, or pressable ceramic framework in the construction of crowns, bridgework, and veneers for 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

• Duceragold Porcelains (K040421)
• Willi Geller Creation Porcelain (K981490)
• NobelRondo Dental Ceramic - Zirconia (K043312)

Submission Summary (Full Text)

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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 consists of a stylized image of a human figure in profile, with three faces overlapping to suggest a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 17, 2014

Talladium Incorporated Mr. Edward Harms Vice President OA/RA 27360 West Muirfield Lane Valencia, CA 91326

Re: K140848

Trade/Device Name: Luminesse Porcelain System Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: September 15, 2014 Received: September 18, 2014

#### Dear Mr. Harms:

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 - Mr. Harms

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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Erin | Keith -S

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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### Section 4: Indications for Use

510(k) Number (if known):

Device Name: Luminesse Porcelain System

Indications for Use:

The Luminesse Porcelain System is dental porcelain material to be used in conjunction with metal, zirconia, or pressable ceramic framework in the construction of crowns and/or bridgework and veneers.

Prescription Use

(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

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Image /page/3/Picture/0 description: The image shows the logo and contact information for Talladium Incorporated. The logo features a stylized "T" with orbiting electrons. The contact information includes the address 27360 West Muirfield Lane, Valencia, California 91355, phone number [phone], fax number [phone], and email address [e-mail].

#### 510(k) Summary

December 15, 2014

Contact: Edward R. Harms, CEO

Tel: [phone] ext: 182

Email: [e-mail]

| General Information | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Luminesse Porcelain |
| Luminesse Porcelain's Assigned 510k | K140848 |
| Common Name | Porcelain powder for clinical use |
| Predicate 510(k) | Duceragold Porcelains (K040421), Willi Geller<br>Creation Porcelain<br>(K981490), NobelRondo Dental Ceramic -<br>Zirconia (K043312) |
| Product Code | EIH |
| Regulation No. | 872.6660 Porcelain Powder for Clinical Use |
| Classification | Class II |
| Review Panel | Dental |
| Manufacturer | Talladium Incorporated |
| Registration # | 2023129 |
| Submission Type | Traditional 510k for a New Device |

#### Device Description:

The Luminesse Porcelain is dental porcelain used by dental technicians to create biocompatible crowns, bridges, and veneers. It consists of three categories: low fusing, high fusing, and zirconia porcelain. The application, indication, and performance is the same for all three categories; therefore, it is a porcelain system. It includes Pressable Ingots, Opaque Powders, Opaque Powders, Opacious Dentins, Dentins, Incisal Powders, Stains, Incisal Transluscents, Dentin Modifiers, Correction Powder, Glaze Powder, Glaze Liquid, Modeling Liquid, and Opaque Liquid. The dental technician will use various components of the system to create the specific, desired dental prosthetic, for the sole use of individual dental patients. It is for prescription use only.

#### Intended Use:

The Luminesse Porcelain is intended to be used by trained dental technicians or on the order of a dental professional. The Luminesse Porcelain is not for use by the general public or over the-counter.

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Image /page/4/Picture/0 description: The image shows the logo and contact information for Talladium Incorporated. The logo features a stylized "T" surrounded by atomic symbols. The contact information includes the address 27360 West Muirfield Lane, Valencia, California 91355, phone number [phone], fax number [phone], and email address [e-mail].

#### Indications for Use:

The Luminesse Porcelain is porcelain material to be used in conjunction with metal, zirconia, or pressable ceramic framework in the construction of crowns and/or bridgework and veneers.

#### Technological Characteristics:

Luminesse Porcelain is used to veneer or press over the appropriate base materials (metal or zirconia). In order to prevent cracking and avoid damage of the restoration due to the thermally-induced stress, the average coefficient of thermal expansion has been adjusted to a coefficient of thermal expansion of the appropriate base materials, which allows fusion to the base materials. This is the main technological characteristic of the dental porcelains in general, and it is shared by the subject device and predicate devices. Bench testing to determine flexural strength, solubility, and glass transition temperature

was conducted in accordance with ISO 6872.

#### Conclusion:

All components found in Luminesse Porcelain have been used in legally marketed devices and were found safe for dental use. It has the same technological characteristics, chemical composition, manufacturing process, and same intended use as the predicate devices. Components of this product have not changed in any way that would adversely affect biocompatibility; therefore, it is determined that no biocompatibility testing is necessary for this product. The Luminesse Porcelain, as designed and manufactured, is as safe and effective as the predicate devices.

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## PREDICATE DEVICES COMPARISON TABLE - LUMINESSE PORCELAIN PRODUCT SIMILARITIES AND DIFFERENCES

| Company<br>Information | US FDA 510(k)<br>Number | Product Name | Indications | Technology | Design/Material Composition |
|---------------------------|-------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Talladium<br>Incorporated | K140848 | Luminesse<br>Porcelain,<br>Low-Fusing | The Luminesse Low-Fusing is<br>porcelain material to be used in<br>conjunction with metal, or<br>pressable ceramic framework in<br>the construction of crowns<br>and/or bridgework and<br>veneers. | TALLADIUM's Luminesse LF (Low Fusing) is a low-fusing glass/leucite<br>ceramic keyed to the *VITA® shade guide. For Porcelain Fused-to-Metal<br>restorations the recommended alloy CTE range for the Luminesse II is<br>13.8 - 14.4 @ 600 ºC. Luminesse LH can be used on All Ceramic (AC),<br>Pressed-to-Metal (PTM) and Fused-to-Metal Restorations (FTM). | Leucite-fortified glass ceramic provided in powder, liquids and<br>pressable pellets delivery designs. |
| Talladium<br>Incorporated | K140848 | Luminesse<br>Porcelain<br>High-Fusing | The Luminesse High-Fusing is<br>porcelain material to be used in<br>conjunction with metal, or<br>pressable ceramic framework in<br>the construction of crowns<br>and/or bridgework and<br>veneers. | TALLADIUM's Luminesse HF (Low Fusing) is a high-fusing glass/leucite<br>ceramic keyed to the *VITA® shade guide for life-like esthetics. For<br>Porcelain Fused-to-Metal restorations the recommended alloy CTE range<br>for the Luminesse HF is 13.8 - 15.1 @ 600 ºC. Luminesse HF can be used<br>on All Ceramic (AC), Pressed-to-Metal (PTM) and Fused-to-Metal<br>Restorations (FTM). In contrast to Luminesse LF, HF offers a higher<br>tensile strength during cyclical firings and higher translucency. | Leucite-fortified glass ceramic provided in powder, liquids and<br>paste designs. |
| Talladium<br>Incorporated | K140848 | Luminesse<br>Porcelain,<br>Zirconia | The Luminesse Zirconia is<br>porcelain material to be used in<br>conjunction with zirconia<br>framework in the construction<br>of crowns and/or bridgework<br>and veneers. | TALLADIUM's Luminesse ZR is a high feldspathic-content veneering<br>porcelain and an ideal match for all zirconia or lithium disilicate<br>substructures. Its 13.2 average CTE provides suitability to zirconia<br>restorations. | Feldspathic porcelain designed specifically foir zirconia<br>substructure restorations. These are provided in liquid and<br>powder application formats. |
| Dentsply<br>International | K040421<br>(Predicate Device) | Duceragold®<br>Porcelains | Preparation of crowns and<br>bridges - veneering metal<br>Framework and copings and<br>veneering pressable ceramic. | Ducera Gold is a low-fusing porcelain used for PFM restorations. At an<br>average CTE of 15.1, it is used successfully on certain metal substrates.<br>SIMILARITIES: Geared toward low-fusing CTE metals to prevent cracking;<br>Available in powder and paste;<br>Instructions of use:<br>(1) Tooth/Dye Preparation<br>(2) Waxing<br>(3) Spruing<br>(4) Investing<br>(5) Burnout<br>(6) Pressing<br>(7) Divesting<br>(8) Opaque firing<br>(9) Apply Porcelain<br>(10) Build-up Dentine and Enamel layers<br>(11) A second firing may be used for fine adjustments and account for<br>shrinkage.<br>(12) A final glaze firing is necessary to achieve the ideal shine of the<br>tooth.<br>DIFFERENCES: Average CTE for Duceragold is higher; FIring temperature<br>used is higher (800C x 750C); Instructions of use (secod firing is not<br>recommended in Duceragold porcelains). | Duceragold porcelain is a silica based low CTE porcelain<br>offered in the powder and liquid formats for metal-based<br>substructures.<br>Specific material makeup of Duceragold were not publicly<br>available likely due to its proprietary value.<br>SIMILARITIES: The application and general basis of the<br>chemistry is substantially equivalent to Luminesse Low-Fusing<br>porcelain; Silica as the main ingredient and pigments are<br>organically based.<br>DIFFERENCES: Unless specific chemistry makeup of<br>Duceragold is known, one cannot compare the material<br>composition. |
| Jensen<br>Industries | K981490<br>(Predicate Device) | Willi Geller<br>Creation CC<br>Porcelain | Willi Geller Creation porcelain is<br>a dental ceramic that is used by<br>dental technicians to fabricate<br>dental restorations including<br>porcelain fused to metal<br>crowns and bridges, laminate<br>veneers, and inlays. | Creation CC is a high-fusing metal-ceramic with unique optical and<br>physical properties. The perfectly coordinated ceramic materials have<br>excellent homogeneity and thus guarantee high flexural strength. The<br>result: a densely sintered structure for pure and non-porous layering<br>with the utmost reliability. At an average 13.3 CTE, it is suitable to<br>Pressed-to-Metal and Fused-to-Metal restorations.<br>SIMILARITIES: Technology created to accomodate suitable metals with<br>higher CTE; Instructions of Use (as described above) are identical.<br>DIFFERENCES: Lower CTE than Luminesse HF CTE range; Not available in<br>paste as Luminesse; slight deviation in Instruction of Use, such as firing<br>temperatures. | Obtained from filed 510(k) Summary: The ceramic powders<br>in the Creation porcelain system are composed in varying<br>proportions of silicon dioxide, aluminum dioxide, sodium<br>oxide, potassium oxide, tin oxide, barium oxide and iron<br>oxide. Chemically stable mixed metal oxides, including spinel<br>baddeleyit, zircon, and periclase phases of zirconium, iron,<br>cobalt, chromium, yttrium, cerium, nickel and zinc oxides, are<br>used in trace amounts for pigmentation. The paste opaques<br>are comprised of ceramic powder fitting this description<br>suspended in glycerol, zinc chloride, sodium acetate,<br>propandiol, and aerosol. The stains are composed of silicon<br>dioxide, aluminum oxide, potassium oxide, tin oxide, barium<br>oxide, iron oxide, and calcium oxide, and chemically stable<br>mixed metal oxides for pigmentation.<br>SIMILARITIES: Most all oxides are present in both Luminesse<br>High-Fusing and Willi Geller Creation CC porcelain. |
| Nobel Biocare<br>USA LLC | K043312<br>(Predicate Device) | NobelRondo<br>Dental<br>Ceramic -<br>Zirconia | NobelRondo Dental Ceramic -<br>Zirconia is a ceramic material<br>intended for veneering<br>substructures such as single<br>crowns, multiple frameworks or<br>abutments made from zirconia. | NobelRondoTM Zirconia offers veneering for zirconia substrates in<br>dental restoration.<br>SIMILARITIES: Instruction of use and CTE.<br>DIFFERENCES: Language in instruction of use (shoulder x neck, which is<br>used in Luminesse Zirconia), | NobelRondo's Ceramic Zirconia is a silica based ceramic<br>offered in the powder for zirconia substructures' restorations<br>Specific material makeup of NobelRondo Ceramics were not<br>publicly available likely due to its proprietary value.<br>SIMILARITIES: The application and general basis of the<br>chemistry is substantially equivalent to Luminesse Zirconia<br>given its specific applicability to Zirconia restorations.<br>DIFFERENCES: Unless specific chemistry makeup of<br>NobelRondo Ceramics is known, one cannot compare the<br>material composition. However, given NobelRondo's product<br>lineup, some of their fluorescent ceramics have a different<br>pigmentation composition. |

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