(258 days)
Not Found
No
The device description and intended use clearly define the product as a dental porcelain material and system, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies are bench tests on material properties.
No
This device is a dental porcelain material used in the construction of crowns, bridges, and veneers. It is a restorative material used by dental professionals to replace or repair dental structures, rather than a device intended for therapy or treatment.
No
The device is a dental porcelain material used for constructing crowns, bridges, and veneers. It is a material used in the manufacturing of prosthetics, not for diagnosing conditions.
No
The device description clearly states it is a dental porcelain material consisting of various powders and liquids used to create physical dental prosthetics. It does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for constructing dental prosthetics (crowns, bridges, veneers) for individual dental patients. This is a restorative and prosthetic application, not a diagnostic one.
- Device Description: The device is a material (dental porcelain) used by dental technicians to create physical dental prosthetics. It's a manufacturing material, not a test or assay.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It doesn't analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- User and Setting: The intended users are dental technicians and dental professionals, and the setting is likely a dental lab or clinic. This aligns with the creation of dental prosthetics, not in vitro diagnostics.
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. The Luminesse Porcelain System does not fit this description.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained dental technicians or on the order of a dental professional.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing to determine flexural strength, solubility, and glass transition temperature was conducted in accordance with ISO 6872.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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 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 Geller |
| Creation 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:
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 (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
| Company
Information | US FDA 510(k)
Number | Product Name | Indications | Technology | Design/Material Composition |
|---------------------------|-------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Talladium
Incorporated | K140848 | Luminesse
Porcelain,
Low-Fusing | The Luminesse Low-Fusing is
porcelain material to be used in
conjunction with metal, or
pressable ceramic framework in
the construction of crowns
and/or bridgework and
veneers. | TALLADIUM's Luminesse LF (Low Fusing) is a low-fusing glass/leucite
ceramic keyed to the *VITA® shade guide. For Porcelain Fused-to-Metal
restorations the recommended alloy CTE range for the Luminesse II is
13.8 - 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 and
pressable pellets delivery designs. |
| Talladium
Incorporated | K140848 | Luminesse
Porcelain
High-Fusing | The Luminesse High-Fusing is
porcelain material to be used in
conjunction with metal, or
pressable ceramic framework in
the construction of crowns
and/or bridgework and
veneers. | TALLADIUM's Luminesse HF (Low Fusing) is a high-fusing glass/leucite
ceramic keyed to the *VITA® shade guide for life-like esthetics. For
Porcelain Fused-to-Metal restorations the recommended alloy CTE range
for the Luminesse HF is 13.8 - 15.1 @ 600 ºC. Luminesse HF can be used
on All Ceramic (AC), Pressed-to-Metal (PTM) and Fused-to-Metal
Restorations (FTM). In contrast to Luminesse LF, HF offers a higher
tensile strength during cyclical firings and higher translucency. | Leucite-fortified glass ceramic provided in powder, liquids and
paste designs. |
| Talladium
Incorporated | K140848 | Luminesse
Porcelain,
Zirconia | The Luminesse Zirconia is
porcelain material to be used in
conjunction with zirconia
framework in the construction
of crowns and/or bridgework
and veneers. | TALLADIUM's Luminesse ZR is a high feldspathic-content veneering
porcelain and an ideal match for all zirconia or lithium disilicate
substructures. Its 13.2 average CTE provides suitability to zirconia
restorations. | Feldspathic porcelain designed specifically foir zirconia
substructure restorations. These are provided in liquid and
powder application formats. |
| Dentsply
International | K040421
(Predicate Device) | Duceragold®
Porcelains | Preparation of crowns and
bridges - veneering metal
Framework and copings and
veneering pressable ceramic. | Ducera Gold is a low-fusing porcelain used for PFM restorations. At an
average 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 for
shrinkage.
(12) A final glaze firing is necessary to achieve the ideal shine of the
tooth.
DIFFERENCES: Average CTE for Duceragold is higher; FIring temperature
used is higher (800C x 750C); Instructions of use (secod firing is not
recommended in Duceragold porcelains). | Duceragold porcelain is a silica based low CTE porcelain
offered in the powder and liquid formats for metal-based
substructures.
Specific material makeup of Duceragold were not publicly
available likely due to its proprietary value.
SIMILARITIES: The application and general basis of the
chemistry is substantially equivalent to Luminesse Low-Fusing
porcelain; Silica as the main ingredient and pigments are
organically based.
DIFFERENCES: Unless specific chemistry makeup of
Duceragold is known, one cannot compare the material
composition. |
| Jensen
Industries | K981490
(Predicate Device) | Willi Geller
Creation CC
Porcelain | Willi Geller Creation porcelain is
a dental ceramic that is used by
dental technicians to fabricate
dental restorations including
porcelain fused to metal
crowns and bridges, laminate
veneers, and inlays. | Creation CC is a high-fusing metal-ceramic with unique optical and
physical properties. The perfectly coordinated ceramic materials have
excellent homogeneity and thus guarantee high flexural strength. The
result: a densely sintered structure for pure and non-porous layering
with the utmost reliability. At an average 13.3 CTE, it is suitable to
Pressed-to-Metal and Fused-to-Metal restorations.
SIMILARITIES: Technology created to accomodate suitable metals with
higher CTE; Instructions of Use (as described above) are identical.
DIFFERENCES: Lower CTE than Luminesse HF CTE range; Not available in
paste as Luminesse; slight deviation in Instruction of Use, such as firing
temperatures. | Obtained from filed 510(k) Summary: The ceramic powders
in the Creation porcelain system are composed in varying
proportions of silicon dioxide, aluminum dioxide, sodium
oxide, potassium oxide, tin oxide, barium oxide and iron
oxide. Chemically stable mixed metal oxides, including spinel
baddeleyit, zircon, and periclase phases of zirconium, iron,
cobalt, chromium, yttrium, cerium, nickel and zinc oxides, are
used in trace amounts for pigmentation. The paste opaques
are comprised of ceramic powder fitting this description
suspended in glycerol, zinc chloride, sodium acetate,
propandiol, and aerosol. The stains are composed of silicon
dioxide, aluminum oxide, potassium oxide, tin oxide, barium
oxide, iron oxide, and calcium oxide, and chemically stable
mixed metal oxides for pigmentation.
SIMILARITIES: Most all oxides are present in both Luminesse
High-Fusing and Willi Geller Creation CC porcelain. |
| Nobel Biocare
USA LLC | K043312
(Predicate Device) | NobelRondo
Dental
Ceramic -
Zirconia | NobelRondo Dental Ceramic -
Zirconia is a ceramic material
intended for veneering
substructures such as single
crowns, multiple frameworks or
abutments made from zirconia. | NobelRondoTM Zirconia offers veneering for zirconia substrates in
dental restoration.
SIMILARITIES: Instruction of use and CTE.
DIFFERENCES: Language in instruction of use (shoulder x neck, which is
used in Luminesse Zirconia), | NobelRondo's Ceramic Zirconia is a silica based ceramic
offered in the powder for zirconia substructures' restorations
Specific material makeup of NobelRondo Ceramics were not
publicly available likely due to its proprietary value.
SIMILARITIES: The application and general basis of the
chemistry is substantially equivalent to Luminesse Zirconia
given its specific applicability to Zirconia restorations.
DIFFERENCES: Unless specific chemistry makeup of
NobelRondo Ceramics is known, one cannot compare the
material composition. However, given NobelRondo's product
lineup, some of their fluorescent ceramics have a different
pigmentation composition. |
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