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.

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.

AI/ML Overview

The provided text describes the Luminesse Porcelain System, a dental porcelain material, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance acceptance criteria.

The document is a 510(k) premarket notification letter and a 510(k) summary. These types of documents focus on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than providing detailed acceptance criteria and performance study data in the way you've requested for an AI/CADe device.

Here's a breakdown of what is available based on your request, and what is missing:

1. A table of acceptance criteria and the reported device performance

Missing. The document does not specify quantitative acceptance criteria (e.g., minimum flexural strength, maximum solubility) that the Luminesse Porcelain System needed to meet.
Reported performance: The document states that "Bench testing to determine flexural strength, solubility, and glass transition temperature was conducted in accordance with ISO 6872." However, the results of these tests (the actual reported device performance values) are not provided in the summary. It only indicates that "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." This implies that the performance was deemed comparable to the predicates, but specific numbers are absent.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing. The document does not describe a "test set" in the context of clinical or AI performance evaluation. The "bench testing" mentioned for flexural strength, solubility, and glass transition temperature would have involved material samples, but the specific sample sizes, provenance, or whether it was retrospective/prospective are not mentioned.

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)

Missing. This information is completely irrelevant to this type of device (dental porcelain) and submission (510(k) for substantial equivalence). Ground truth and expert adjudication are concepts typically associated with medical diagnostic devices, especially those involving image analysis or expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing. See point 3.

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

Missing. See point 3. This device is a material, not a diagnostic tool or an AI/CADe system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Missing. See point 3.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Missing. See point 3. The "ground truth" for a material device like this would typically be its physical and chemical properties as measured by standardized tests (like ISO 6872), compared against established standards or predicate device properties.

8. The sample size for the training set

Missing. This concept of a "training set" is for AI/machine learning devices, which this medical device is not.

9. How the ground truth for the training set was established

Missing. See point 8.

Summary

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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 (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 Industry and Consumer Education 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 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 (661) 295-0900, fax number (661) 295-0895, and email address info@talladium.com.

510(k) Summary

December 15, 2014

Contact: Edward R. Harms, CEO

Tel: 661-295-0900 ext: 182

Email: eddie@talladium.com

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 GellerCreation Porcelain(K981490), NobelRondo Dental Ceramic -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:

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 (661) 295-0900, fax number (661) 295-0895, and email address info@talladium.com.

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

CompanyInformation	US FDA 510(k)Number	Product Name	Indications	Technology	Design/Material Composition
TalladiumIncorporated	K140848	LuminessePorcelain,Low-Fusing	The Luminesse Low-Fusing isporcelain material to be used inconjunction with metal, orpressable ceramic framework inthe construction of crownsand/or bridgework andveneers.	TALLADIUM's Luminesse LF (Low Fusing) is a low-fusing glass/leuciteceramic keyed to the *VITA® shade guide. For Porcelain Fused-to-Metalrestorations the recommended alloy CTE range for the Luminesse II is13.8 - 14.4 @ 600 ºC. Luminesse LH can be used on All Ceramic (AC),Pressed-to-Metal (PTM) and Fused-to-Metal Restorations (FTM).	Leucite-fortified glass ceramic provided in powder, liquids andpressable pellets delivery designs.
TalladiumIncorporated	K140848	LuminessePorcelainHigh-Fusing	The Luminesse High-Fusing isporcelain material to be used inconjunction with metal, orpressable ceramic framework inthe construction of crownsand/or bridgework andveneers.	TALLADIUM's Luminesse HF (Low Fusing) is a high-fusing glass/leuciteceramic keyed to the *VITA® shade guide for life-like esthetics. ForPorcelain Fused-to-Metal restorations the recommended alloy CTE rangefor the Luminesse HF is 13.8 - 15.1 @ 600 ºC. Luminesse HF can be usedon All Ceramic (AC), Pressed-to-Metal (PTM) and Fused-to-MetalRestorations (FTM). In contrast to Luminesse LF, HF offers a highertensile strength during cyclical firings and higher translucency.	Leucite-fortified glass ceramic provided in powder, liquids andpaste designs.
TalladiumIncorporated	K140848	LuminessePorcelain,Zirconia	The Luminesse Zirconia isporcelain material to be used inconjunction with zirconiaframework in the constructionof crowns and/or bridgeworkand veneers.	TALLADIUM's Luminesse ZR is a high feldspathic-content veneeringporcelain and an ideal match for all zirconia or lithium disilicatesubstructures. Its 13.2 average CTE provides suitability to zirconiarestorations.	Feldspathic porcelain designed specifically foir zirconiasubstructure restorations. These are provided in liquid andpowder application formats.
DentsplyInternational	K040421(Predicate Device)	Duceragold®Porcelains	Preparation of crowns andbridges - veneering metalFramework and copings andveneering pressable ceramic.	Ducera Gold is a low-fusing porcelain used for PFM restorations. At anaverage CTE of 15.1, it is used successfully on certain metal substrates.SIMILARITIES: Geared toward low-fusing CTE metals to prevent cracking;Available in powder and paste;Instructions of use:(1) Tooth/Dye Preparation(2) Waxing(3) Spruing(4) Investing(5) Burnout(6) Pressing(7) Divesting(8) Opaque firing(9) Apply Porcelain(10) Build-up Dentine and Enamel layers(11) A second firing may be used for fine adjustments and account forshrinkage.(12) A final glaze firing is necessary to achieve the ideal shine of thetooth.DIFFERENCES: Average CTE for Duceragold is higher; FIring temperatureused is higher (800C x 750C); Instructions of use (secod firing is notrecommended in Duceragold porcelains).	Duceragold porcelain is a silica based low CTE porcelainoffered in the powder and liquid formats for metal-basedsubstructures.Specific material makeup of Duceragold were not publiclyavailable likely due to its proprietary value.SIMILARITIES: The application and general basis of thechemistry is substantially equivalent to Luminesse Low-Fusingporcelain; Silica as the main ingredient and pigments areorganically based.DIFFERENCES: Unless specific chemistry makeup ofDuceragold is known, one cannot compare the materialcomposition.
JensenIndustries	K981490(Predicate Device)	Willi GellerCreation CCPorcelain	Willi Geller Creation porcelain isa dental ceramic that is used bydental technicians to fabricatedental restorations includingporcelain fused to metalcrowns and bridges, laminateveneers, and inlays.	Creation CC is a high-fusing metal-ceramic with unique optical andphysical properties. The perfectly coordinated ceramic materials haveexcellent homogeneity and thus guarantee high flexural strength. Theresult: a densely sintered structure for pure and non-porous layeringwith the utmost reliability. At an average 13.3 CTE, it is suitable toPressed-to-Metal and Fused-to-Metal restorations.SIMILARITIES: Technology created to accomodate suitable metals withhigher CTE; Instructions of Use (as described above) are identical.DIFFERENCES: Lower CTE than Luminesse HF CTE range; Not available inpaste as Luminesse; slight deviation in Instruction of Use, such as firingtemperatures.	Obtained from filed 510(k) Summary: The ceramic powdersin the Creation porcelain system are composed in varyingproportions of silicon dioxide, aluminum dioxide, sodiumoxide, potassium oxide, tin oxide, barium oxide and ironoxide. Chemically stable mixed metal oxides, including spinelbaddeleyit, zircon, and periclase phases of zirconium, iron,cobalt, chromium, yttrium, cerium, nickel and zinc oxides, areused in trace amounts for pigmentation. The paste opaquesare comprised of ceramic powder fitting this descriptionsuspended in glycerol, zinc chloride, sodium acetate,propandiol, and aerosol. The stains are composed of silicondioxide, aluminum oxide, potassium oxide, tin oxide, bariumoxide, iron oxide, and calcium oxide, and chemically stablemixed metal oxides for pigmentation.SIMILARITIES: Most all oxides are present in both LuminesseHigh-Fusing and Willi Geller Creation CC porcelain.
Nobel BiocareUSA LLC	K043312(Predicate Device)	NobelRondoDentalCeramic -Zirconia	NobelRondo Dental Ceramic -Zirconia is a ceramic materialintended for veneeringsubstructures such as singlecrowns, multiple frameworks orabutments made from zirconia.	NobelRondoTM Zirconia offers veneering for zirconia substrates indental restoration.SIMILARITIES: Instruction of use and CTE.DIFFERENCES: Language in instruction of use (shoulder x neck, which isused in Luminesse Zirconia),	NobelRondo's Ceramic Zirconia is a silica based ceramicoffered in the powder for zirconia substructures' restorationsSpecific material makeup of NobelRondo Ceramics were notpublicly available likely due to its proprietary value.SIMILARITIES: The application and general basis of thechemistry is substantially equivalent to Luminesse Zirconiagiven its specific applicability to Zirconia restorations.DIFFERENCES: Unless specific chemistry makeup ofNobelRondo Ceramics is known, one cannot compare thematerial composition. However, given NobelRondo's productlineup, some of their fluorescent ceramics have a differentpigmentation composition.

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Regulation Number and Section

§ 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.