VITA AKZENT LC is a light-curing methacrylatebased stain/ glaze system for extraoral surface characterization of dental restorations made of hybrid ceramic, resin veneering materials, CAD/CAM composites, prefabricated teeth and denture base resins. It can also be used for internal characterization with the layering technique of veneering composites.

AI/ML Overview

The document describes the VITA Akzent® LC, a light-curing methacrylate-based stain/glaze system for extraoral surface characterization of dental restorations. The acceptance criteria and the study proving the device meets these criteria are outlined in the "Non-Clinical Performance Testing" and "Biocompatibility" sections.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Biocompatibility: Conformance to ISO 10993-1:2009 (Biological evaluation of medical devices) and ISO 7405:2004 (Dentistry – Evaluation of biocompatibility of medical devices).	A biocompatibility assessment was performed on VITA Akzent® AC in accordance with ISO 10993-1:2009 and ISO 7405:2008. The assessment supports that VITA Akzent® LC is biocompatible and concludes that the device is substantially equivalent to the predicate device in terms of biocompatibility.
Performance: General safety and effectiveness for its intended use as a coating material for resin fillings.	"Performance and biocompatibility testing prove that the subject device, in a liquid form, does not impact the safety and effectiveness of the product... The adhesion performance testing conducted against the reference device, shows a more favorable efficacy during bench testing."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a distinct "test set" in the traditional sense of a clinical study with human subjects. The evaluation was primarily based on non-clinical performance testing and biocompatibility assessment.

For biocompatibility, the testing was conducted in-vitro/non-clinical based on recognized international standards. Specific sample sizes for these tests (e.g., number of specimens tested for cytotoxicity, irritation, etc.) are not explicitly stated in this summary.
For adhesion performance, "bench testing" was conducted. The sample size for this testing is not explicitly stated.
The data provenance is not explicitly stated but is presumed to be from laboratory testing as per the cited ISO standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable and not provided in the document because the assessment was based on non-clinical (laboratory) testing and established international standards for biocompatibility and material performance, rather than clinical efficacy studies requiring expert evaluation of patient data.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided as the evaluation was based on objective laboratory testing against established standards, not human interpretation of results requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of VITA Akzent® AC."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This concept is not applicable to this device. VITA Akzent® LC is a material (a stain/glaze system), not an algorithm or an AI-powered diagnostic tool. Its performance is determined by its physical and chemical properties as evaluated through non-clinical laboratory tests.

7. The Type of Ground Truth Used:

The ground truth for demonstrating the device's performance relies on:

Established international standards: ISO 10993-1 (Biological evaluation of medical devices) and ISO 7405 (Dentistry – Evaluation of biocompatibility of medical devices).
Bench test results: Specifically, "adhesion performance testing" against a reference device.
Material composition equivalence: Comparison of the chemical composition to predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. As VITA Akzent® LC is a material and not an AI/ML algorithm, there is no "training set" in the conventional sense. Its development would likely involve
iterative formulation and testing, but not machine learning training.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable and not provided, as there is no "training set" for this type of device. The formulation and development of the material are based on scientific principles of polymer chemistry and dental material science, combined with performance testing.

Summary

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November 22, 2021

VITA Zahnfabrik GmbH H Rauter & Co % Lindsay Tilton Regulatory Affairs Consultant VITA North America 22705 Savi Ranch Parkway, Suite 100 Yorba Linda. California 92887

Re: K211854

Trade/Device Name: VITA Akzent LC Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material For Resin Fillings Regulatory Class: Class II Product Code: EBD Dated: August 25, 2021 Received: August 27, 2021

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.

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

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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 (QS) 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 Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K211854

Device Name VITA Akzent LC

Indications for Use (Describe)

VITA AKZENT LC Indication range:

Restorations made of hybrid ceramic
· Restorations made of light-curing veneering material
· Restorations made of CAD/CAM composites
· Prefabricated Teeth
· Denture bases

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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510(k) Summary

K211854

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 ConsultantVITA North America, Inc.22705 Savi Ranch Parkway, Suite 100Yorba Linda, CA 92887Establishment Reg. No. 2082832Phone (800) 828-3839Fax (714) 221-6759E-mail: Itilton@vitanorthamerica.com

Date Prepared

November 16,2021

י Trade/Device Name Vita Akzent® LC
י Classification Name Coating Material for Resin Filling
Regulation Number 21 CFR 872.3310
י Product Code EBD

Predicate Devices

Vident's VITA Enamic Stains– K123761 – Primary Predicate Device

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GC America's Optiglaze - K133836 - Reference Device

Device Description

VITA Akzent® LC VITA AKZENT LC is a light-curing methacrylatebased stain/ glaze system for extraoral surface characterization of dental restorations made of hybrid ceramic, resin veneering materials, CAD/CAM composites, prefabricated teeth and denture base resins. It can also be used for internal characterization with the layering technique of veneering composites.

Indications for Use

VITA AKZENT LC Indication range:

Restorations made of hybrid ceramic
Restorations made of light-curing veneering material
Restorations made of CAD/CAM composites
Prefabricated Teeth
Denture bases

Technological Characteristics

VITA Akzent® LC provides a light cured glaze system similar to the predicate device formulas. The composition of the VITA Akzent®LC and the predicates are based on similar materials, therefore this difference does not impact the substantial equivalence.

Non-Clinical Performance Testing

VITA Akzent® LC meets the applicable requirements of the following FDA recognized standards:

. ISO 10993-1:2009 – Biological evaluation of medical devices
I ISO 7405:2004 – Dentistry – Evaluation of biocompatibility of medical devices

Biocompatibility

A biocompatibility assessment was performed on VITA Akzent® 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 Akzent® LC is biocompatible and concludes that the device is substantially equivalent to the predicate device in terms of biocompatibility.

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Clinical Performance Data

Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA Akzent® AC.

Comparison to Predicate Devices

Below is a table showing the predicate device comparison.

	Subject Device	Primary Predicate Device	Reference Device
Device Name	VITA Akzent® LC - K211854	Vident's VITA EnamicStains- K123761	GC America's Optiglaze- K133836
Device Classification	Coating, Filling Material,Resin	Coating,Filling Material,Resin	Coating,FillingMaterial, Resin
Product Code	EBD	EBD	EBD
Indication for use	VITA AKZENT LC Indicationrange:• Restorations made ofhybrid ceramic• Restorationsmade of light curingveneering material• Restorations made ofCAD/CAMComposites• PrefabricatedTeeth• Denture bases	VITA Enamic Stains areindicated for shadecustomization andcharacterization of thesurface of dentalrestorations made ofhybrid ceramic-resin andresin materials.	For characterizationof direct and indirectcompositerestorations, acrylicdenture base andartificial acrylicteeth.For obtaining surfacesmoothness andwear resistance ofrestorations made ofcompositeresin, acrylic denturebase and artificialacrylic teeth.
TechnologicalCharacteristics	Liquid	Powder and Liquid	Liquid
Principle ofoperation	For characterization andglazing restorations	For characterization andglazing restorations	For characterizationand glazingrestorations
Materialcomposition	A mixture of	A mixture of	Multifuctional acrylate,

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methacrylates, initiators andother non-hazardous	methacrylates, initiatorsand other non-hazardous	methyl methacrylate,silicafiller, photo initiator,pigment
additions	additions

Differences between Subject and Predicate Devices

The predicate device indication for use was submitted with a more generic indication. Below is how the predicate device is similar in indications for Akzent LC.

The predicate device was designed states that it's intended for customization and characterization of the surface of dental restorations made of hybrid ceramic-resin and resin materials. These terms are similar to the subject's device indication of Restorations made of hybrid ceramic, light-curing veneering material (resin materials), CAD/CAM composites (resin materials) and Denture bases (resin materials)

Both cover the same indications, and no additional indications are added to the subject device, therefore this does not affect the substantial equivalence or efficacy and safety.

The reference device was used since the subject device product is in liquid form as is the reference device. The primary predicate uses a liquid and a powder form. The same mechanism is used, and the subject device is considered a subset of the primary predicate device and equivalent to the reference device. Performance and biocompatibility testing prove that the subject device, in a liquid form, does not impact the safety and effectiveness of the product and shows. The adhesion performance testing conducted against the reference device, shows a more favorable efficacy during bench testing.

Conclusion

Based on the above comparative tables, it is concluded that VITA Akzent®LC is equivalent to the predicate device. VITA Akzent® LC has similar indications for use and similar material composition as the predicate devices.

Regulation Number and Section

§ 872.3310 Coating material for resin fillings.

(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.