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.

AI/ML Overview

This document is a 510(k) Premarket Notification for the VITA Lumex® AC, a porcelain powder for clinical use, and not a study describing the acceptance criteria and performance of a device that meets those criteria.

Therefore, I cannot provide the requested information, which includes:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts and their qualifications for establishing ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study results.
Standalone (algorithm-only) performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document states: "Non-Clinical Performance Testing" on page 5, indicating that "Bench test results allowed us to conclude that VITA Lumex® AC is substantially equivalent to the predicate device for its intended use." It also explicitly states "Clinical Performance Data: Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA Lumex® AC."

This filing relies on bench testing and comparison to predicates, not specific clinical performance studies with acceptance criteria as requested in your prompt.

Summary

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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.

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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 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

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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)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K193434

510(k) Summary

Submitter	VITA Zahnfabrik H.Rauter GmbH Co.Spitelgasse 3Bad Sackingen, D-79713GermanyEstablishment Reg. No. 1000625496
Contact	Bernd WalkerHead of Regulatory Affairs and Quality SystemPhone (+49) 7761 562-361Fax (+49) 7761 562-384B.Walker@vita-zahnfabrik.com
Official Correspondent	Lindsay TiltonRegulatory Affairs & Compliance ManagerVITA North America, Inc.22705 Savi Ranch Parkway, Suite 100Yorba Linda, CA 92887Establishment Reg. No. 2082832Phone (925)699-9091Fax (714) 221-6759E-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

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K193434

Predicate Devices

Vident's VITA VM Porcelains- K060441 - Primary Predicate Device

Device Description

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

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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 PredicateDevice
Device Name	VITA Lumex® AC	Vident's VITA VMPorcelains– K060441
Device Classification	Porcelain powderfor clinical use	Porcelain powderfor clinical use
Product Code	EIH	EIH
Indication for use	VITA Lumex® AC isused to veneer thefollowing:• Full and partialveneering ofzirconia• Full and partialveneering of lithiumdisilicate	Vita VM® porcelainsare indicated foruse as a veneeringmaterial for fixedprosthesis incrowns, bridges,and dental implantabutments. Thesedevices are used inprosthetic dentistry

Comparison to Predicate Devices

VITA Lumex AC - 510(k) Premarket Notification

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	• Partial veneeringof feldspar ceramic• Reconstructionwithout asubstructure	by forming aporcelain veneer onto a ceramic ormetal substructureinto the shape of adental crown.
	Materials:
	• Zirconiasubstructures (CTEapprox. 10.0 to 10.5x 10-6 K-1)
	• Glass-ceramicsubstructures (CTEapprox. 9.0 to 10.5x 10-6 K-1)
Components	Powder and Liquid	Powder and Liquid
Principle ofoperation	for the fabrication ofrestorations	for the fabrication ofrestorations

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.

Regulation Number and Section

§ 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.