Who is the manufacturer of VITA Akzent LC?

Vita Zahnfabrik GmbH H Rauter & CO filed the 510(k) submission for VITA Akzent LC (K211854).

What is the FDA product code for VITA Akzent LC?

EBD. It is classified under 21 CFR 872.3310 as a Class 2 device in the Dental panel.

What is the regulatory pathway for VITA Akzent LC?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like VITA Akzent LC?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VITA Akzent LC

Q: What are the predicate devices for VITA Akzent LC?

Vident's VITA Enamic Stains (K123761).

K211854 · Vita Zahnfabrik GmbH H Rauter & CO · EBD · Nov 22, 2021 · Dental

Device Facts

Record ID	K211854
Device Name	VITA Akzent LC
Applicant	Vita Zahnfabrik GmbH H Rauter & CO
Product Code	EBD · Dental
Decision Date	Nov 22, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3310
Device Class	Class 2

Intended 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

Device Story

VITA Akzent LC is a light-curing, methacrylate-based stain and glaze system; used for extraoral surface characterization of dental restorations (hybrid ceramic, resin veneering, CAD/CAM composites, prefabricated teeth, denture bases) and internal characterization via layering technique. Operated by dental professionals in a clinical or laboratory setting. Device is applied to restoration surfaces; light-cured to achieve characterization, surface smoothness, and wear resistance. Output is a modified, characterized dental restoration surface. Benefits include improved aesthetic customization and surface properties of dental prosthetics.

Clinical Evidence

Bench testing only. No human clinical testing performed. Biocompatibility assessment conducted per ISO 10993-1:2009 and ISO 7405:2004. Adhesion performance testing compared to reference device demonstrated favorable efficacy.

Technological Characteristics

Light-curing methacrylate-based liquid stain/glaze system. Composition includes methacrylates, initiators, and pigments. Biocompatibility compliant with ISO 10993-1 and ISO 7405.

Indications for Use

Indicated for shade customization and surface characterization of dental restorations including hybrid ceramics, light-curing veneering materials, CAD/CAM composites, prefabricated teeth, and denture bases.

Regulatory Classification

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.

Predicate Devices

Vident's VITA Enamic Stains (K123761)

Reference Devices

GC America's Optiglaze (K133836)

Related Devices

K101621 — LITE ART · Shofu Dental Corp. · Aug 23, 2010
K133836 — OPTIGLAZE COLOR · GC America, Inc. · Mar 6, 2014
K123761 — VITA ENAMIC STAINS · Innovation Meditech GmbH · Mar 1, 2013
K050920 — CZR PRESS LF STAINS · Noritake Co., Inc. · May 11, 2005
K090718 — BELLUS SHADING KIT · 3M Espe AG Dental Products · Sep 21, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is in blue and white. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | |-------------------------------------------------| |-------------------------------------------------| 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 #### K211854 | 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 Consultant VITA North America, Inc. 22705 Savi Ranch Parkway, Suite 100 Yorba Linda, CA 92887 Establishment Reg. No. 2082832 Phone (800) 828-3839 Fax (714) 221-6759 E-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 {4}------------------------------------------------ # 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. {5}------------------------------------------------ # 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 Enamic Stains- K123761 | GC America's Optiglaze - K133836 | | Device Classification | Coating, Filling Material, Resin | Coating,Filling Material, Resin | Coating,Filling Material, Resin | | Product Code | EBD | EBD | EBD | | Indication 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 | VITA Enamic Stains are indicated for shade customization and characterization of the surface of dental restorations made of hybrid ceramic-resin and resin materials. | For characterization of direct and indirect composite restorations, acrylic denture base and artificial acrylic teeth. For obtaining surface smoothness and wear resistance of restorations made of composite resin, acrylic denture base and artificial acrylic teeth. | | Technological Characteristics | Liquid | Powder and Liquid | Liquid | | Principle of operation | For characterization and glazing restorations | For characterization and glazing restorations | For characterization and glazing restorations | | Material composition | A mixture of | A mixture of | Multifuctional acrylate, | {6}------------------------------------------------ | methacrylates, initiators and other non-hazardous | methacrylates, initiators and other non-hazardous | methyl methacrylate, silica filler, 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.