(223 days)
Not Found
No
The document describes a ceramic veneering system and its materials. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies are bench tests comparing the material to a predicate device, not evaluating algorithmic performance.
No.
VITA Lumex® AC is a dental veneering ceramic used to create prosthetics, not to prevent, diagnose, or treat a medical condition or disease.
No
The device is a veneering ceramic system used for reconstructing dental restorations, not for diagnosing medical conditions.
No
The device description clearly states it is a "natural low-fusing veneering ceramic system" provided in "powder form" in "glass jars," indicating it is a physical material, not 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 "veneer" dental restorations (zirconia, lithium disilicate, feldspar ceramic) and for "reconstruction without a substructure." This describes a material used in the fabrication of dental prosthetics.
- Device Description: The description details a "veneering ceramic system" used in conjunction with a liquid to create dental restorations.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test a sample from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide diagnostic information. This device is a material used in the creation of dental devices, which falls under a different regulatory category.
N/A
Intended Use / Indications for Use
VITA Lumex® AC is used to veneer the following:
- · Full and partial veneering of zirconia
- · Full and partial veneering of lithium disilicate
- Partial veneering of feldspar ceramic
- Reconstruction without a substructure
Materials: - · Zirconia substructures (CTE approx. 10.0 to 10.5 x 10-6 K-1)
- · Glass-ceramic substructures (CTE approx. 9.0 to 10.5 x 10-6 K-1)
Product codes
EIH
Device Description
VITA Lumex® AC is a natural low-fusing veneering ceramic system that is suitable for veneering all ceramic substructures. VITA LUMEX AC standard layering consists of the two Materials DENTINE and ENAMEL. The color-bearing DENTINE materials, which provide good coverage, offer the perfect precondition for the preparation of veneers with intensive shades. With this two-layer alternative, VITA offers an ideal solution for the reproduction of optimal shade results in case of thin walls. Additionally, the intensive shade effect of the DENTINE permits a more generous use of the ENAMEL materials, which create the desired translucency. The user is able to prepare a natural restoration with a lifelike appearance with only two layers. This product is provided non-sterile in glass jars in a powder form to be used in conjunction with the Vita low fusing liquid.
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
Not Found
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 Testing:
Bench test results allowed us to conclude that VITA Lumex® AC is substantially equivalent to the predicate device for its intended use.
Biocompatibility:
A biocompatibility assessment was performed on VITA Lumex® AC in accordance with ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process, and ISO 7405:2008 – Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry. This assessment supports that VITA Lumex® AC is biocompatible and concludes that the device is substantially equivalent to the predicate device in terms of biocompatibility.
Clinical Performance Data:
Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA Lumex® AC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 21, 2020
VITA Zahnfabrik GmbH H Rauter & Co % Lindsav Tilton Regulatory Affairs Consultant VITA North America 22705 Savi Ranch Parkway, Suite 100 Yorba Linda. California 92887
Re: K193434
Trade/Device Name: Vita Lumex Ac Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: March 21, 2020 Received: April 23, 2020
Dear Lindsay Tilton:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193434
Device Name VITA Lumex® AC
Indications for Use (Describe)
VITA Lumex® AC is used to veneer the following:
- · Full and partial veneering of zirconia
- · Full and partial veneering of lithium disilicate
- Partial veneering of feldspar ceramic
- Reconstruction without a substructure
Materials:
- · Zirconia substructures (CTE approx. 10.0 to 10.5 x 10-6 K-1)
- · Glass-ceramic substructures (CTE approx. 9.0 to 10.5 x 10-6 K-1)
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Submitter | VITA Zahnfabrik H.Rauter GmbH Co.
Spitelgasse 3
Bad Sackingen, D-79713
Germany
Establishment Reg. No. 1000625496 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Bernd Walker
Head of Regulatory Affairs and Quality System
Phone (+49) 7761 562-361
Fax (+49) 7761 562-384
B.Walker@vita-zahnfabrik.com |
| Official Correspondent | Lindsay Tilton
Regulatory Affairs & Compliance Manager
VITA North America, Inc.
22705 Savi Ranch Parkway, Suite 100
Yorba Linda, CA 92887
Establishment Reg. No. 2082832
Phone (925)699-9091
Fax (714) 221-6759
E-mail: ltilton@vitanorthamerica.com |
| Date Prepared | July 15, 2020 |
- " Trade/Device Name Vita Lumex® AC
- " Classification Name Porcelain powder for clinical use
- " Regulation Number 21 CFR 872.6660
- י EIH Product Code
4
K193434
Predicate Devices
Vident's VITA VM Porcelains- K060441 - Primary Predicate Device
Device Description
VITA Lumex® AC is a natural low-fusing veneering ceramic system that is suitable for veneering all ceramic substructures. VITA LUMEX AC standard layering consists of the two Materials DENTINE and ENAMEL. The color-bearing DENTINE materials, which provide good coverage, offer the perfect precondition for the preparation of veneers with intensive shades. With this two-layer alternative, VITA offers an ideal solution for the reproduction of optimal shade results in case of thin walls. Additionally, the intensive shade effect of the DENTINE permits a more generous use of the ENAMEL materials, which create the desired translucency. The user is able to prepare a natural restoration with a lifelike appearance with only two layers. This product is provided non-sterile in glass jars in a powder form to be used in conjunction with the Vita low fusing liquid.
Indications for Use
VITA Lumex® AC is used to veneer the following:
- Full and partial veneering of zirconia
- Full and partial veneering of lithium disilicate
- Partial veneering of feldspar ceramic
- Reconstruction without a substructure
Materials:
- · Zirconia substructures (CTE approx. 10.0 to 10.5 x 10-6 K-1)
- Glass-ceramic substructures (CTE approx. 9.0 to 10.5 x 10-6 K-1
Technological Characteristics
VITA Lumex® AC provides a lower fusing veneering ceramic similar to the predicate device formula.
The composition of the VITA Lumex®AC and the predicates are based on similar materials, therefore this difference does not impact the substantial equivalence.
Non-Clinical Performance Testing
2 VITA Lumex AC - 510(k) Premarket Notification
5
VITA Lumex® AC meets the applicable requirements of the following FDA recognized standards:
- . DIN EN ISO 6872 2015 - Dentistry – Ceramic Materials
- ISO 10993-1:2009 - Biological evaluation of medical devices
- ISO 7405:2004 – Dentistry – Evaluation of biocompatibility of medical devices
Bench test results allowed us to conclude that VITA Lumex® AC is substantially equivalent to the predicate device for its intended use.
Biocompatibility
A biocompatibility assessment was performed on VITA Lumex® AC in accordance with ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process, and ISO 7405:2008 – Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry. This assessment supports that VITA Lumex® AC is biocompatible and concludes that the device is substantially equivalent to the predicate device in terms of biocompatibility.
Clinical Performance Data
Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA Lumex® AC.
| | Subject Device | Primary Predicate
Device |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | VITA Lumex® AC | Vident's VITA VM
Porcelains– K060441 |
| Device Classification | Porcelain powder
for clinical use | Porcelain powder
for clinical use |
| Product Code | EIH | EIH |
| Indication for use | VITA Lumex® AC is
used to veneer the
following:
• Full and partial
veneering of
zirconia
• Full and partial
veneering of lithium
disilicate | Vita VM® porcelains
are indicated for
use as a veneering
material for fixed
prosthesis in
crowns, bridges,
and dental implant
abutments. These
devices are used in
prosthetic dentistry |
Comparison to Predicate Devices
VITA Lumex AC - 510(k) Premarket Notification
6
| | • Partial veneering
of feldspar ceramic
• Reconstruction
without a
substructure | by forming a
porcelain veneer on
to a ceramic or
metal substructure
into the shape of a
dental crown. |
|---------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| | Materials: | |
| | • Zirconia
substructures (CTE
approx. 10.0 to 10.5
x 10-6 K-1) | |
| | • Glass-ceramic
substructures (CTE
approx. 9.0 to 10.5
x 10-6 K-1) | |
| Components | Powder and Liquid | Powder and Liquid |
| Principle of
operation | for the fabrication of
restorations | for the fabrication of
restorations |
The predicate device indication for use was submitted with a more generic indication. Below are how the predicate device is similar in indications for Lumex AC.
The predicate device was designed as a high-fusing, fine-structure feldspar ceramic for Zr02 substructures partially stabilized with yttrium in the CTE range of approx. 10.5. The predicate's Low-melting materials in eight different shades based on the fine-structure veneering ceramic. They are especially used for individualizing substructure-free restorations made.
The predicate was designed as a high-fusing, fine-structure feldspar ceramic for VITA Glass Ceramic in CET range approx. 12.3 mixed with VITA Low Fusing Modelling liquid
Both cover the same indications and no additional indications are added to the subject device, therefore this does not affect the substantial equivalence.
Conclusion
Information provided in this application demonstrates that the differences between VITA Lumex®AC and predicate devices do not affect safety and effectiveness, therefore VITA Lumex®AC is substantially equivalent to the predicate devices.