(422 days)
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.
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.
The provided text is a 510(k) Pre-market Notification for a dental device, Luminesse Shaded Zirconia SZ. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new AI/CADeX device. Therefore, much of the requested information regarding AI/CADeX studies is not available in the document.
However, I can extract the acceptance criteria and performance data for the physical properties of the dental material as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Tests | Acceptance Criteria (ISO 6872 Requirements for dental ceramic) | Luminesse Shaded Zirconia SZ (Reported Device Performance) | Predicate Device (BruzXir™ Shaded) | Similarities and Differences |
|---|---|---|---|---|
| Flexural Strength | > 800 MPa | Average: > 1,000 MPa | Average: 1000 - 1200 MPa Max: 1465 MPa | Both devices meet minimum ISO 6872 requirement by over 30%. Similarities in flexural strength indicate both devices perform the same. |
| Coefficient of Thermal Expansion (CTE) | Not explicitly stated in table, but relative comparison to predicate | Average ≈ 10.3 x 10-6/K | Average ≈ 11 x 10-6/K | Negligible difference, indicating similar behavior during CAD/CAM machining. |
| Vickers Hardness | Not explicitly stated in table, but relative comparison to predicate | Average ≈ 52 (H.V.) | Average ≈ 49 (H.V.) | Small difference of 3 (H.V.) reported between average values. This small difference does not impact performance. |
| Density (sintered) | Not explicitly stated in table, but relative comparison to predicate | >6.05 g/cm³ | 5.90 g/cm³ | Within experimental error, dimensions are similar. Minor difference in density does not impact performance compared to predicate. |
| Chemical Composition | Not explicitly stated in table, but relative comparison to predicate | ZRO2+HfO2+Y2O3+Al2O3 >90% | ZRO2+HfO2+Y2O3+Al2O3 >90% | Identical chemical composition for major chemical makeup. |
| Biocompatibility Assessment | Based on ISO 10993-1, predicate device results were accepted | Expected to meet requirement | PASS (Cytotoxicity, Sensitization, Irritation) | The proposed device is made of the same material as the predicate, with similar manufacturing and body contact. Given the predicate's successful biocompatibility tests, the proposed device's biocompatibility performance is considered similar. |
Regarding the study proving the device meets acceptance criteria:
The study conducted was a non-clinical performance testing and a comparison against a predicate device to establish substantial equivalence.
2. Sample size used for the test set and data provenance:
- Sample size: Not explicitly stated for each specific test (e.g., number of samples for flexural strength). The document mentions "performance testing (flexural strength, shading consistency and coefficient of thermal expansion – CTE) in accordance with ISO 6872:2008."
- Data provenance: Not explicitly stated (e.g., country of origin). The study was conducted by Talladium, Inc. in Valencia, CA, which implies the testing was likely done in the US, but this is not explicitly stated for the raw data. It is a retrospective comparison to the predicate device's data and ISO standards.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- This type of information is not applicable to this document as it concerns physical material properties and biocompatibility, not diagnostic image interpretation or clinical judgment requiring expert consensus on ground truth. The "ground truth" here is defined by international standards (ISO 6872:2008 for dental ceramic).
4. Adjudication method for the test set:
- Not applicable. See point 3. This is not a study requiring adjudication of expert opinions.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is not an AI/CADeX device or a device requiring human efficacy studies of this nature.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/CADeX device. The performance tests were done on the physical material itself.
7. The type of ground truth used:
- The "ground truth" for the physical properties (flexural strength, CTE, etc.) is established by international standards (ISO 6872:2008) for dental ceramic materials.
- For biocompatibility, the ground truth is established by ISO 10993-1: Biological evaluation of medical devices, with reference to the predicate device's successful biocompatibility testing.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/CADeX device that learns from data.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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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.
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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)
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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, 91355P: (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 usewith CAD/CAM technology or manual milling machines toproduce all-ceramic patient specific dental restorations - fullcontour crowns and bridges, for anterior and posterior location -as prescribed by a dentist. |
| Device Description: | Luminesse Shaded Zirconia SZ are used for full contour zirconiadental restorations utilizing CAD/CAM system for design andmanufactured. Once designed and manufactured, LuminesseShaded Zirconia SZ will undergo sintering. The shaded zirconiaproducts are pre-shaded to meet all 16 VITA® shading guide;hence, no further coloring is necessary post-sintering. Oncesintered, Luminesse Shaded Zirconia SZ will exhibit maximumstrength for posterior and anterior dental restorations. |
| Non-clinical Performance: | The functionality of Luminesse Shaded Zirconia SZ and theirconformance 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 ZirconiaSZ(K152023) | BruxZir™ Shaded(K130924) |
| Indication for Use | Luminesse Shaded ZirconiaSZ blanks/discs are indicatedfor use with CAD/CAMtechnology or manual millingmachines to produce all-ceramic custom dentalrestorations - full contourcrowns and bridges, foranterior and posterior location- as prescribed by a dentist. | The device is indicated for use bydental technicians in theconstruction of custom made allceramic restorations for anteriorand posterior location.(While the Indication for Usestatement is not identical to that ofthe proposed device, the differencein wording does not raise anyconcerns or issues about the use ofthe proposed device). |
| Product Information(quantities, types) | Over 50 options in disc andblock shapes for differentmilling systems. | About 25 different options in discsfor Sirona's milling system. |
| Dimensions | Disc: 95 and 98 mm diameterdiscs per 10mm, 12mm,14mm, 16mm, 18mm, 22mm,25mm and 30mm thicknesses.Blocks: | 98.5 and 100 mm diameter discsper 12mm, 15mm, 20mm and25mm thicknesses. |
| For Amann Girrbach (millingsystem): | ||
| 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 and19mm); | ||
| 40mm x 15mm x (14mm and19mm); | ||
| 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
| PERFORMANCETESTS | Talladium's ShadedZR(K152023) | BruxZirTM Shaded(K130924)Predicate device | Similarities andDifferences |
|---|---|---|---|
| FlexuralStrength | Average: > 1,000 MPaISO 6872requirements:>800 MPa | Average: 1000 - 1200MPaMaximum: 1465 MPa | The flexural strength forboth proposed andpredicate devices areslightly different, but bothmeet minimum ISO 6872requirement by over 30%,minimum.Based on the values, thesimilarities in flexuralstrength indicate bothdevices perform the same. |
| Coefficient ofThermalExpansion | Average ≈ 10.3 x 10-6/K | Average ≈ 11 x 10-6/K | The difference in thecoefficients of thermalexpansion betweenproposed and predicatedevices are negligible.The negligible differencein CTEs show they willbehave very similarlyduring CAD/CAMmachining. |
| VickersHardness | Average ≈ 52 (H.V.) | Average ≈ 49 (H.V.) | A small difference inVickers's hardness of 3 isreported based oncomparison of averagevalues between predicateand proposed devices. |
| This small difference inVickers's hardness doesnot impact performance. | |||
| Density | >6.05 g/cm³ (sintered) | 5.90 g/cm³ | Within experimental error,the dimensions betweenproposed and predicatedevices are similar.The minor difference indensity does not impactthe performance of theproposed device comparedto predicate. |
| ChemicalComposition:ZrO2+HfO2+Y2O3+Al2O3 | >90% | >90% | The chemical compositionwith relation to the majorchemical makeup areidentical betweenproposed and predicatedevices. |
| BiocompatibilityAssessment (perISO 10993-1) | Biocompatibility testswere not performed.However, abiocompatibility finalassessment wasperformed, in asystematic approach, inaccordance with ISO10993-1. Thisconcludes that thefollowingbiocompatibilityconclusions can beachieved: | Bruxzir Shaded wastested for Cytotoxicity,Sensitization andIrritation. The tests showthe following results: | Since the proposed deviceis made of same material(classified as porcelainpowder) as the predicatedevice and have similarmanufacturing and type ofbody contact properties,and, in addition, predicatedevice manufacturer hasperformedbiocompatibility tests, weconcluded using ourmedical device designvalidation and verification |
| Cytotoxic(IX MEMextraction) | Expectedtomeetrequirement. | PASS | process (which includesFMEA and scientific andclinical literature review)that the proposed device |
| method at37°C)Sensitization(ISOIntracutaneousStudy, Extract0.9% sodiumchloride USPsolution (SC)and sesame oil,NF (SO)) | Expected to meetrequirement. | PASS | biocompatibilityperformance is similar topredicate device. |
| Irritation andSkinSensitizationStudy, Extract0.9% sodiumchloride USPand sesame oil,NF (SO)) | Expected to meetrequirement. | 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.
§ 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.