(89 days)
Luminesse Anterior Zirconia 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 location - as prescribed by a dentist.
Luminesse Anterior Zirconia are used for full contour Zirconia dental restorations utilizing CAD/CAM system for design and manufactured. Once designed and manufactured, Luminesse Anterior Zirconia will undergo sintering. The anterior Zirconia products are pre-shaded to meet all 16 VITA® shading guide; hence, no further coloring is necessary post-sintering. Once sintered, Luminesse Anterior Zirconia will exhibit maximum strength anterior dental restorations.
The provided text describes the Luminesse Anterior Zirconia device, which is a material used for dental restorations. The document is a 510(k) summary submitted to the FDA, indicating that the device is seeking substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 6872) | Reported Device Performance (Luminesse Anterior Zirconia) |
|---|---|
| Flexural Strength: > 600 MPa (for anterior use) | 622 MPa (average) |
| Coefficient of Thermal Expansion: Not explicitly stated, but compared to predicate. | 10.5 x 10^-6/K |
| Density: Not explicitly stated, but compared to predicate. | >6.05 g/cm³ (sintered) |
| Biocompatibility: | |
| (1) Cytotoxic Tests (Agar diffusion test and filter diffusion test) | (1) 0 level |
| (2) Short-term systemic toxicity (oral route) | (2) No systemic toxicity |
| (3) Test for irritation and delayed-type hypersensitivity | (3) No hypersensitivity |
| (4) Hemolytic Test | (4) Hemolysis rate, < 5% |
| (5) Ames mutagenicity test | (5) Mutagenicity Negative |
| (6) Oral mucous membrane irritation test | (6) No oral mucous irritation |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance tests (flexural strength, CTE, density, and biocompatibility tests). There is no information provided regarding the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the document describes performance testing of a material, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method
This information is not applicable as the document describes performance testing of a material, not a diagnostic device requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable as the document describes performance testing of a material, not a diagnostic device with human-in-the-loop performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the document describes performance testing of a material.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria appears to be based on established material science standards and biological safety assessments. For flexural strength, the benchmark is ISO 6872 requirements for anterior use (>600 MPa). For biocompatibility, standard toxicology and irritation tests are used to demonstrate safety, with acceptance criteria like "0 level" for cytotoxicity and "no systemic toxicity."
8. The Sample Size for the Training Set
This information is not applicable as this device is a material, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as 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 features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black, and the text is also black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2015
Talladium, Inc. Mr. Luiz Galdino Regulatory Affairs Specialist 27360 W. Muirfield Lane Valencia, California, 91355
Re: K150266
Trade/Device Name: Luminesse Anterior Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: July 19, 2015 Received: July 24, 2015
Dear Mr. Galdino:
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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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 yours,
Tina
Kiang -S
for 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Luminesse Anterior Zirconia
Indications for Use (Describe)
Luminesse Anterior Zirconia 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 location - as prescribed by a dentist.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| FORM FDA 3881 (8/14) | |
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Section 5– 510(k) SUMMARY
| Date: | October 14, 2015 |
|---|---|
| Sponsor: | Talladium's Inc. |
| 27360 W. Muirfield Lane, Valencia, CA, 91355 | |
| P: (661) 295-0900 | |
| F: (661) 295-0895 | |
| Primary Contact Person: | Edward R. Harms - raqa@talladium.com |
| Secondary Contact Person: | Luiz S. Galdino - luiz@talladium.com |
| Trade Name: | Luminesse Anterior Zirconia |
| Common Name: | Porcelain Powder for Clinical Use |
| Device Classification: | Class II |
| Classification Number: | 21 CFR 872.6660 |
| Classification Panel: | Dental |
| CDHR Product Code: | EIH |
| Device Description: | Luminesse Anterior Zirconia are used for full contour Zirconia dentalrestorations utilizing CAD/CAM system for design and manufactured.Once designed and manufactured, Luminesse Anterior Zirconia willundergo sintering. The anterior Zirconia products are pre-shaded to meetall 16 VITA® shading guide; hence, no further coloring is necessarypost-sintering. Once sintered, Luminesse Anterior Zirconia will exhibitmaximum strength anterior dental restorations. |
| Intended Use: | Luminesse Anterior Zirconia is intended for use by dental technicians inthe construction of anterior and posterior all-ceramic restoration withdesign and manufacturing aid of CAD/CAM technology. |
| Indications for Use: | Luminesse Anterior Zirconia blanks/discs are indicated for use withCAD/CAM technology or manual milling machines to produce all-ceramic custom dental restorations - full contour crowns and bridges foranterior location - as prescribed by a dentist. |
| Performance Data: | The functionality of Luminesse Anterior Zirconia and their conformanceto design input was assessed based on performance testing (flexuralstrength, shading consistency and coefficient of thermal expansion -CTE). |
| Determination ofSubstantial Equivalence: | The table below compares key characteristics that provides similaritiesand substantial equivalence of the predicate device BruxZir™ Anterior(K143330) and the proposed device, Luminesse Anterior Zirconia. It is tothe best of our knowledge that the comparison table below demonstratesthat the proposed Luminesse Anterior Zirconia is essentially the same ascurrently marketed devices for the same indications for use, and itvalidates our claim of substantial equivalence to predicate Class IIdevices under the classification of porcelain powder for clinical use (21CFR 872.6660) that have previously been found to be substantially |
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equivalent. If there are any differences between the predicate and proposed devices, they are insignificant and, therefore, does not introduce any new issues. Both the proposed device, Luminesse Anterior Zirconia, and the predicate device BruxZir™ Anterior (K143330) consist of general porcelain powder material, have the same indication for use and have the same intended use.
| Company | Talladium Inc. | Prismatik DentalCraft, Inc. | Chemical Composition:ZrO2+HfO2+Y2O3+Al2O3 | >90% | >90% |
|---|---|---|---|---|---|
| 510(k) Number | Luminesse AnteriorZirconia (new submission) | BruxZir™ Anterior (K143330) | Biocompatibility | ||
| Intended Use | Luminesse AnteriorZirconia is intended for useby dental technicians in theconstruction of anterior andposterior all-ceramicrestoration with design andmanufacturing aid ofCAD/CAM technology. | Intended for production of highlyesthetic full-contour Zirconia dentalrestorations utilizing the CAD/CAMsystem for design and manufacture. | (1) Cytotoxic Tests (Agardiffusion test andfilter dissusion test) | (1) 0 level | |
| Indication of Use | Luminesse AnteriorZirconia blanks/discs areindicated for use withCAD/CAM technology ormanual milling machines toproduce all-ceramic customdental restorations - fullcontour crowns and bridges,for anterior location - asprescribed by a dentist. | The device is indicated for use bydental technicians in the constructionof custom made all ceramicrestorations for anterior and posteriorlocation. | (2) Short-term systemictoxicity (oral route) | (2) No systemictoxicity | |
| Product Information(quantities, types) | Over 50 options in discs andblocks | Same | (3) Test for irritationand delayed-typehypersensitivity | (3) Nohypersensitivity | Biocompatible and non-toxicClaims are made by manufacturer. |
| Dimensions | Variety | Variety | (4) Hemolytic Test | (4) Hemolysis rate, <5% | |
| VITA® Shade | All 16 shades | All 16 shades | (5) Ames mutagenicitytest | (5) MutagenicityNegative | |
| Flexural Strength | 622 MPa (average)ISO 6872 requirements foranterior> 600 MPa | Meets ISO 6872 requirements | (6) Oral mucousmembrane irritationtest | (6) No oral mucousirritation | |
| Coefficient of Thermal Expansion | 10.5 x 10-6/K | 11 x 10-6/K | |||
| Density | >6.05 g/cm3 (sintered) | 6.046 g/cm3 |
Luminesse® Anterior Zirconia and Bruxzir ™ Anterior Comparison Table
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October 14, 2015 Talladium, Inc.
Conclusion:
From the chart above, the differences between the subject device and the predicate device are primarily due to shapes, dimensions and shading availability. Furthermore, the technical performance data supplied for both the subject device and predicate device are not identical but very similar within the expected specifications for porcelain powder used for dental application. Hence, both subject and predicate device can be considered substantially equivalent.
In summary, a comparison between the predicate and subject devices show that:
- They have the same intended use (as described above); -
- Share technological characteristics and; -
- -Contain biocompatibility similarities.
Regards,
Edward R. Ham
X Edward R. Harms (President/CEO)
§ 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.