(89 days)
Not Found
No
The summary describes a material (zirconia blanks) used in CAD/CAM systems for dental restorations. It focuses on the material properties and manufacturing process, with no mention of AI or ML being used in the design, manufacturing, or analysis of the restorations. The CAD/CAM technology mentioned is a standard digital manufacturing process, not inherently AI/ML driven in this context.
No
The device is a material (zirconia blanks/discs) used to produce dental restorations, not a device that itself provides therapy. It is a component used in the manufacturing of a medical device rather than a therapeutic device.
No
Explanation: The device is used to produce dental restorations (crowns and bridges) and does not involve diagnosing medical conditions. It is a material used for manufacturing, not a diagnostic tool.
No
The device is a physical material (zirconia blanks/discs) used in the manufacturing of dental restorations, not a software program.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Luminesse Anterior Zirconia blanks/discs are used to manufacture dental restorations (crowns and bridges). They are a material used in the creation of a medical device that is placed in the body, not a device that tests samples from the body.
- Intended Use: The intended use clearly states the product is for producing dental restorations for anterior locations. This is a restorative function, not a diagnostic one.
- Device Description: The description focuses on the material properties and manufacturing process of the dental restoration, not on analyzing biological samples.
- Performance Studies: The performance studies listed (flexural strength, shading consistency, CTE) are related to the physical properties and performance of the dental material itself, not its ability to diagnose or monitor a medical condition based on biological samples.
Therefore, based on the provided information, the Luminesse Anterior Zirconia blanks/discs are a dental material used to create a medical device (dental restoration), and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior location
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental technicians
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)
The functionality of Luminesse Anterior Zirconia and their conformance to design input was assessed based on performance testing (flexural strength, shading consistency and coefficient of thermal expansion - CTE).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength: 622 MPa (average) ISO 6872 requirements for anterior > 600 MPa
Coefficient of Thermal Expansion: 10.5 x 10-6/K
Density: >6.05 g/cm3 (sintered)
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 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) |
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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| FORM FDA 3881 (8/14) | |
|---|---|
| ---------------------- | -- |
Page 1 of 1
EF PSC Publishing Services (301) 443-6740
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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 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. | |
| Intended Use: | Luminesse Anterior Zirconia is intended for use by dental technicians in |
| the construction of anterior and posterior all-ceramic restoration with | |
| design and manufacturing aid of CAD/CAM technology. | |
| Indications for Use: | 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. | |
| Performance Data: | The functionality of Luminesse Anterior Zirconia and their conformance |
| to design input was assessed based on performance testing (flexural | |
| strength, shading consistency and coefficient of thermal expansion - | |
| CTE). | |
| Determination of | |
| Substantial Equivalence: | The table below compares key characteristics that provides similarities |
| and substantial equivalence of the predicate device BruxZir™ Anterior | |
| (K143330) and the proposed device, Luminesse Anterior Zirconia. It is to | |
| the best of our knowledge that the comparison table below demonstrates | |
| that the proposed Luminesse Anterior Zirconia is essentially the same as | |
| currently marketed devices for the same indications for use, and it | |
| validates our claim of substantial equivalence to predicate Class II | |
| devices under the classification of porcelain powder for clinical use (21 | |
| CFR 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 Anterior
Zirconia (new submission) | BruxZir™ Anterior (K143330) | Biocompatibility | | |
| Intended Use | Luminesse Anterior
Zirconia is intended for use
by dental technicians in the
construction of anterior and
posterior all-ceramic
restoration with design and
manufacturing aid of
CAD/CAM technology. | Intended for production of highly
esthetic full-contour Zirconia dental
restorations utilizing the CAD/CAM
system for design and manufacture. | (1) Cytotoxic Tests (Agar
diffusion test and
filter dissusion test) | (1) 0 level | |
| Indication of Use | 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. | The device is indicated for use by
dental technicians in the construction
of custom made all ceramic
restorations for anterior and posterior
location. | (2) Short-term systemic
toxicity (oral route) | (2) No systemic
toxicity | |
| Product Information
(quantities, types) | Over 50 options in discs and
blocks | Same | (3) Test for irritation
and delayed-type
hypersensitivity | (3) No
hypersensitivity | Biocompatible and non-toxic
Claims are made by manufacturer. |
| Dimensions | Variety | Variety | (4) Hemolytic Test | (4) Hemolysis rate, 600 MPa | Meets ISO 6872 requirements | (6) Oral mucous
membrane irritation
test | (6) No oral mucous
irritation | |
| 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
5
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)