(422 days)
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No
The summary describes a material (zirconia blanks) used in CAD/CAM dental restorations. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML for design, analysis, or manufacturing control beyond standard CAD/CAM processes.
No
The device is a material (zirconia blanks/discs) used by dental technicians to produce dental restorations, not a device that directly treats or provides therapy to a patient.
No
Explanation: The device is a dental material (zirconia blanks/discs) used to create restorations, not to diagnose medical conditions. Its use is in the manufacturing process of the restoration, not in the diagnostic process.
No
The device description clearly states it is a physical material (zirconia blanks/discs) used in the manufacturing of dental restorations. It mentions CAD/CAM technology for design and manufacturing, but the device itself is the physical material, not the 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 produce patient-specific dental restorations (crowns and bridges) using CAD/CAM technology or manual milling. This is a medical device used for treatment and restoration within the body.
- Device Description: The description focuses on the material properties and manufacturing process of the zirconia blanks for dental restorations.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are typically used to test samples like blood, urine, tissue, etc., to provide diagnostic information. This device is a material used to create a physical restoration for the patient's mouth.
N/A
Intended Use / Indications for Use
Luminesse Shaded Zirconia SZ blanks/discs are indicated for use with CAD/CAM technology or manual milling machines to produce all-ceramic patient specific dental restorations - full contour crowns and bridges for anterior and posterior location - as prescribed by a dentist.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Luminesse Shaded Zirconia SZ are used for full contour zirconia dental restorations utilizing CAD/CAM system for design and manufactured. Once designed and manufactured, Luminesse Shaded Zirconia SZ will undergo sintering. The shaded zirconia products are pre-shaded to meet all 16 VITA® shading guide; hence, no further coloring is necessary post-sintering. Once sintered, Luminesse Shaded Zirconia SZ will exhibit maximum strength for posterior and anterior dental restorations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior and posterior location (dental)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist
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)
Non-clinical Performance: The functionality of Luminesse Shaded Zirconia SZ and their conformance to design input was assessed based on physical performance testing (flexural strength, shading consistency and coefficient of thermal expansion – CTE) in accordance with ISO 6872:2008. In addition, biocompatibility information on cytotoxicity, sensitivity and irritation is based upon a biocompatibility assessment conducted in accordance with ISO 10993-1: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management. Per ISO 10993-1, Luminesse Shaded Zirconia SZ is considered a permanent contact mucosal membrane surface device. Biocompatibility testing was not performed since identical materials are used in the predicate device with the same type and duration of patient contact. Our device is comprised of identical materials and manufacturing methods as the predicate device and other legally marketed devices and does not introduce any new issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength: Average: > 1,000 MPa, ISO 6872 requirements: > 800 MPa
Coefficient of Thermal Expansion: Average ≈ 10.3 x 10^-6/K
Vickers Hardness: Average ≈ 52 (H.V.)
Density: > 6.05 g/cm³ (sintered)
Chemical Composition (ZrO2+HfO2+Y2O3+Al2O3): >90%
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2016
Talladium, Inc. Mr. Edward Harms President/CEO 27360 West Muirfield Lane Valencia, California 91355
Re: K152023
Trade/Device Name: Luminesse Shaded Zirconia SZ Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: June 7, 2016 Received: June 20, 2016
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.
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 devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Susan Runco, DDS, MA
Tina Kiang, Ph.D. Acting 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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DEPARTMENT OF HEAL11 AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No.0910.0120 Expiration Date: January 31,2017 Se& PRA Statement below.
510(k) Number (if known) K152023
Device Name Luminesse Shaded Zirconia SZ
Indications for Use (Describe)
Luminesse Shaded Zirconia SZ blanks/discs are indicated for use with CAD/CAM technology or manual milling machines to produce all-ceramic patient specific dental restorations - full contour crowns and bridges for anterior and posterior location - as prescribed by a dentist.
Type of Use {Select one or both, as applicable)
Presaiption Use (Part 21 CFR 801 Subpart D)
O Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
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Image /page/3/Picture/0 description: The image shows a logo with a stylized letter 'T' at the center. The 'T' is depicted in a solid, dark color, giving it a bold appearance. Encircling the 'T' are orbital paths, reminiscent of an atom's structure, with small, dark circles representing electrons. To the right of the 'T', there is a 'TM' symbol, indicating that the logo is trademarked.
510(k) SUMMARY
| Date: | September 13, 2016 |
|---|---|
| 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 Shaded Zirconia SZ |
| Common Name: | Porcelain Powder for Clinical Use |
| Device Classification: | Class II |
| Classification Number: | 21 CFR 872.6660 |
| Classification Panel: | Dental |
| CDHR Product Code: | EIH |
| Indications for Use: | Luminesse Shaded Zirconia SZ blanks/discs are indicated for use |
| with CAD/CAM technology or manual milling machines to | |
| produce all-ceramic patient specific dental restorations - full | |
| contour crowns and bridges, for anterior and posterior location - | |
| as prescribed by a dentist. | |
| Device Description: | Luminesse Shaded Zirconia SZ are used for full contour zirconia |
| dental restorations utilizing CAD/CAM system for design and | |
| manufactured. Once designed and manufactured, Luminesse | |
| Shaded Zirconia SZ will undergo sintering. The shaded zirconia | |
| products are pre-shaded to meet all 16 VITA® shading guide; | |
| hence, no further coloring is necessary post-sintering. Once | |
| sintered, Luminesse Shaded Zirconia SZ will exhibit maximum | |
| strength for posterior and anterior dental restorations. | |
| Non-clinical Performance: | The functionality of Luminesse Shaded Zirconia SZ and their |
| conformance to design input was assessed based on physical |
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Image /page/4/Picture/0 description: The image shows a logo with a stylized letter 'T' at its center. The 'T' is depicted in a solid, dark color, giving it a bold appearance. Encircling the 'T' are orbital paths, reminiscent of an atomic model, with small, dark circles representing electrons or particles along these paths. The overall design suggests a blend of technology and scientific concepts, possibly representing a company or organization involved in technological innovation or scientific research.
performance testing (flexural strength, shading consistency and coefficient of thermal expansion – CTE) in accordance with ISO 6872:2008. In addition, biocompatibility information on cytotoxicity, sensitivity and irritation is based upon a biocompatibility assessment conducted in accordance with ISO 10993-1: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management. Per ISO 10993-1, Luminesse Shaded Zirconia SZ is considered a permanent contact mucosal membrane surface device. Biocompatibility testing was not performed since identical materials are used in the predicate device with the same type and duration of patient contact. Our device is comprised of identical materials and manufacturing methods as the predicate device and other legally marketed devices and does not introduce any new issues.
Substantial Equivalence: The table below compares key characteristics that provide similarities and differences of the predicate device BruxZir™ Shaded (K130924) and the proposed device, Luminesse Shaded Zirconia SZ. If there are any differences between the predicate and proposed devices, they are with respect marketable disc dimensions and they are manufactured to be used exclusively with Sirona's milling system (Cerec and inLab MC XL milling machines). These differences do not introduce any new issues. Both the proposed device, Luminesse Shaded Zirconia SZ, and the predicate device BruxZir™ Shaded (K130924) consist of general porcelain powder material, have the same indication for use and are made following similar manufacturing methods in the industry.
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Image /page/5/Picture/0 description: The image is a logo that features a stylized letter 'T' at the center, with elements resembling an atomic model surrounding it. The 'T' is depicted in a solid, dark color, giving it a bold and prominent appearance. Orbit-like lines encircle the 'T', each containing a small, dark circle, which are reminiscent of electrons in an atomic structure. The overall design suggests a connection to technology, science, or innovation, with the atomic model adding a layer of sophistication and modernity to the logo.
Lumi nes s e® Shaded Zi rc oni a and B r uxzi r ™ Shaded C ompar i s on T abl e
| Company | Talladium Inc. | Prismatik DentalCraft, Inc. |
|---|---|---|
| 510(k) Number | Luminesse Shaded Zirconia | |
| SZ | ||
| (K152023) | BruxZir™ Shaded | |
| (K130924) | ||
| Indication for Use | Luminesse Shaded Zirconia | |
| SZ blanks/discs are indicated | ||
| for use with CAD/CAM | ||
| technology or manual milling | ||
| machines to produce all- | ||
| ceramic custom dental | ||
| restorations - full contour | ||
| crowns and bridges, for | ||
| anterior and posterior location |
- as prescribed by a dentist. | The device is indicated for use by
dental technicians in the
construction of custom made all
ceramic restorations for anterior
and posterior location.
(While the Indication for Use
statement is not identical to that of
the proposed device, the difference
in wording does not raise any
concerns or issues about the use of
the proposed device). |
| Product Information
(quantities, types) | Over 50 options in disc and
block shapes for different
milling systems. | About 25 different options in discs
for Sirona's milling system. |
| Dimensions | Disc: 95 and 98 mm diameter
discs per 10mm, 12mm,
14mm, 16mm, 18mm, 22mm,
25mm and 30mm thicknesses.
Blocks: | 98.5 and 100 mm diameter discs
per 12mm, 15mm, 20mm and
25mm thicknesses. |
| | For Amann Girrbach (milling
system): | |
| | 89mm x 71mm x (10mm,
12mm, 14mm, 16mm, 18mm,
20mm, 22mm, 25mm); | |
| | For Custom for Lava | |
| | 72mm x 42mm x (10mm,
12mm, 14mm, 16mm, 18mm,
20mm, 22mm, 25mm); | |
| | For Sirona inLab: | |
| | 15mm x 20mm x (14mm and
19mm); | |
| | 40mm x 15mm x (14mm and
19mm); | |
| | 55mm x 19mm x 16mm; | |
| | 65mm x 25mm x 22mm. | |
| VITA® Shade | All 16 VITA® shades | All 16 VITA® shades |
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Image /page/6/Picture/0 description: The image shows a logo with a stylized letter 'T' at the center. The 'T' is depicted as a solid, dark shape. Orbiting around the 'T' are elliptical paths, reminiscent of atomic orbitals, with small, dark circles representing electrons or particles. The logo has a futuristic or scientific feel due to the atomic orbital design.
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Image /page/7/Picture/0 description: The image is a black and white logo. The logo features a stylized letter "T" in a bold, sans-serif font. The "T" is positioned in the center of the logo and is oriented vertically. Encircling the "T" are three elliptical orbits, reminiscent of an atomic model. Each orbit has a solid black circle, resembling an electron, positioned along its path. To the right of the base of the "T", there is a "TM" symbol, indicating a trademark.
Summary of Performance Tests – Talladium Shaded ZR
| PERFORMANCE
TESTS | Talladium's Shaded
ZR
(K152023) | BruxZirTM Shaded
(K130924)
Predicate device | Similarities and
Differences |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Flexural
Strength | Average: > 1,000 MPa
ISO 6872
requirements:
800 MPa | Average: 1000 - 1200
MPa
Maximum: 1465 MPa | The flexural strength for
both proposed and
predicate devices are
slightly different, but both
meet minimum ISO 6872
requirement by over 30%,
minimum.
Based on the values, the
similarities in flexural
strength indicate both
devices perform the same. |
| Coefficient of
Thermal
Expansion | Average ≈ 10.3 x 10-6/K | Average ≈ 11 x 10-6/K | The difference in the
coefficients of thermal
expansion between
proposed and predicate
devices are negligible.
The negligible difference
in CTEs show they will
behave very similarly
during CAD/CAM
machining. |
| Vickers
Hardness | Average ≈ 52 (H.V.) | Average ≈ 49 (H.V.) | A small difference in
Vickers's hardness of 3 is
reported based on
comparison of average
values between predicate
and proposed devices. |
| | | | This small difference in
Vickers's hardness does
not impact performance. |
| Density | >6.05 g/cm³ (sintered) | 5.90 g/cm³ | Within experimental error,
the dimensions between
proposed and predicate
devices are similar.
The minor difference in
density does not impact
the performance of the
proposed device compared
to predicate. |
| Chemical
Composition:
ZrO2+HfO2+Y2
O3+Al2O3 | >90% | >90% | The chemical composition
with relation to the major
chemical makeup are
identical between
proposed and predicate
devices. |
| Biocompatibility
Assessment (per
ISO 10993-1) | Biocompatibility tests
were not performed.
However, a
biocompatibility final
assessment was
performed, in a
systematic approach, in
accordance with ISO
10993-1. This
concludes that the
following
biocompatibility
conclusions can be
achieved: | Bruxzir Shaded was
tested for Cytotoxicity,
Sensitization and
Irritation. The tests show
the following results: | Since the proposed device
is made of same material
(classified as porcelain
powder) as the predicate
device and have similar
manufacturing and type of
body contact properties,
and, in addition, predicate
device manufacturer has
performed
biocompatibility tests, we
concluded using our
medical device design
validation and verification |
| Cytotoxic
(IX MEM
extraction) | Expected
to
meet
requirement. | PASS | process (which includes
FMEA and scientific and
clinical literature review)
that the proposed device |
| method at
37°C)
Sensitization
(ISO
Intracutaneous
Study, Extract
0.9% sodium
chloride USP
solution (SC)
and sesame oil,
NF (SO)) | Expected to meet
requirement. | PASS | biocompatibility
performance is similar to
predicate device. |
| Irritation and
Skin
Sensitization
Study, Extract
0.9% sodium
chloride USP
and sesame oil,
NF (SO)) | Expected to meet
requirement. | PASS | |
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Image /page/8/Picture/0 description: The image is a logo that features a stylized letter 'T' at the center, with an atomic symbol surrounding it. The 'T' is depicted in a solid, dark color, giving it a bold and prominent appearance. The atomic symbol consists of elliptical orbits with small, dark circles representing electrons, creating a sense of science or technology.
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Image /page/9/Picture/0 description: The image is a black and white logo. The logo features a stylized letter "T" in the center, with a three-dimensional appearance. Orbiting around the "T" are elliptical paths, each containing a solid black circle, resembling an atom model. To the right of the "T" is the "TM" symbol, indicating a trademark.
Conclusion: Based upon the chemical composition, non-clinical performance testing and comparison of technology with the predicate device, the subject device is substantially equivalent to the predicate device, Bruxzir Shaded.