Variolink Esthetic LC:
– Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays and veneers)

Only use Variolink Esthetic LC for restorations with a low thickness of <2mm that have sufficient translucency (e.g. restorations made of IPS e.max R HT).

Variolink Esthetic DC:

Adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays, partial crowns, crowns, bridges).
Restorations made of opaque ceramics, e.q. oxide ceramics, can only be permanently cemented if an adhesive is additionally used that is separately light-cured.

Variolink Esthetic Trv-In
To evaluate the overall effect of the restoration in conjunction with the various Variolink Esthetic shades prior to permanent cementation.

Device Description

Variolink® Esthetic is a color-stable adhesive luting system for the permanent cementation of ceramic and composite resin restorations. Variolin Esthet6ic is offered in a purely light-curing (LC) and dual-curing (DC) version. Try-In pastes are also included for shade matching purposes. The materials are offered in five shade gradations (Light+, Light, Neutral, Warm and Warm+)

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental device, Variolink® Esthetic. It includes a comparison to a predicate device and a brief summary of testing performed. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance, nor details about a comprehensive study proving acceptance criteria were met as typically found in clinical trial reports or detailed performance studies for AI/medical imaging devices.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on chemical composition, physical properties, and indications for use, rather than presenting a detailed performance study against specific acceptance criteria for an AI-based device.

Therefore, I cannot directly answer your request about acceptance criteria and the study proving the device meets them in the format you provided because the necessary details are not present in the given text.

Based on the information provided, here's what can be extracted and what is missing:

Missing Information (Not provided in the document):

A table of acceptance criteria and the reported device performance: The document mentions that the device has been tested and designed in accordance with certain ISO standards (ISO 4049:2009 for physical properties and EN ISO 10993-1:2009 / EN ISO 7405:2008 for biocompatibility). However, it does not list specific acceptance criteria values (e.g., "flexural strength must be > X MPa") or the actual reported performance values (e.g., "flexural strength was Y MPa") against those criteria. It only states that the device was designed and tested in accordance with these standards.
Sample sized used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/imaging device requiring expert ground truth for interpretation.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For physical/chemical properties, the "ground truth" would be the standard measurement methods defined by the ISO/EN standards. For biocompatibility, it's about meeting the safety profiles outlined in the standards.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

What is present:

Device Name: Variolink® Esthetic
Predicate Device: Variolink II (K971372)
Type of tests performed:
- Physical properties (in accordance with ISO 4049:2009): film thickness, Depth of Cure, sensitivity to ambient light, working time, flexural strength, water sorption, solubility, and radiopacity.
- Biocompatibility testing (in accordance with EN ISO 10993-1:2009 and EN ISO 7405:2008).
Conclusion: The device is substantially equivalent to the predicate device based on comparison of chemical composition, physical properties, and indications for use.

To fully answer your question, information typically found in detailed test reports or clinical studies would be needed, which is beyond the scope of this 510(k) summary document.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be moving forward.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 25,2014

Ivoclar Vivadent, Inc. Donna Marie Hartnett Director QA/Regulatory Affairs 175 Pineview Drive Amherst, New York 14228

Re: K142389

Trade/Device Name: Variolink® Esthetic Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: II Product Code: EBF Dated: August 8. 2014 Received: August 27, 2014

Dear Ms. Hartnett:

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,

Susan Runno DDS, MA

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

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Indications for Use

510(k) Number (if known): K142389

Device Name: Variolink® Esthetic

Indications For Use:

Variolink Esthetic LC:

– Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays and veneers)

Only use Variolink Esthetic LC for restorations with a low thickness of <2mm that have sufficient translucency (e.g. restorations made of IPS e.max R HT).

Variolink Esthetic DC:

Adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays, partial crowns, crowns, bridges).
Restorations made of opaque ceramics, e.g. oxide ceramics, can only be permanently cemented if an adhesive is additionally used that is separately light-cured.

Variolink Esthetic Trv-In

To evaluate the overall effect of the restoration in conjunction with the various Variolink Esthetic shades prior to permanent cementation.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

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510(K) SUMMARY Variolink Esthetic

Image /page/3/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo consists of the company name in blue, with the words "Ivoclar" stacked on top of "Vivadent". Above the company name is a semi-circle of green and blue squares. Below the company name is the company slogan, "passion vision innovation" in black.

Contact: Donna Marie Hartnett

Company: Ivoclar Vivadent. AG Bendererstrasse 2, Schaan, FL-9494, Liechtenstein +423-235-3535

November 25, 2014 Date Prepared:

Variolink® Esthetic Proprietary Name:

Classification Name: Material, Tooth Shade, Resin (872.3690) (Classification Code EBF)

Predicate Device: Variolink II (K971372)

Device Description: Variolink® Esthetic is a color-stable adhesive luting system for the permanent cementation of ceramic and composite resin restorations. Variolin Esthet6ic is offered in a purely light-curing (LC) and dual-curing (DC) version. Try-In pastes are also included for shade matching purposes. The materials are offered in five shade gradations (Light+, Light, Neutral, Warm and Warm+)

Intended Use: Variolink Esthetic LC:

Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays and veneers)
Only use Variolink Esthetic LC for restorations with a low thickness of <2mm that have sufficient translucency (e.g. restorations made of IPS e.max R HT).

Variolink Esthetic DC:

Adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays,partial crowns, crowns, bridges).
Restorations made of opaque ceramics, e.q. oxide ceramics, can only be permanently cemented if an adhesive is additionally used that is separately light-cured.

Variolink Esthetic Try-In

To evaluate the overall effect of the restoration in conjunction with the various Variolink Esthetic shades prior to permanent cementation.

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510(K) SUMMARY Variolink Esthetic

Image /page/4/Picture/1 description: The image is the logo for Ivoclar Vivadent. The words "ivoclar vivadent" are in blue, with "ivoclar" on top and "vivadent" on the bottom. Above the words is a semi-circle of green and blue dots. The dots are larger in the center and smaller on the ends.

passion vision innovation

Comparison to Predicate: The predicate device to which Variolink® Esthetic has been compared is Variolink II (K971372). For this application, Variolink® Esthetic has been compared to its predicate with regard to chemical composition, physical properties, and indications for use. The comparison shows that Variolink® Esthetic is substantially equivalent to the predicate device.

Predicate - Variolink II K971372	Subject Device
Variolink II is a dual-curing (light- and self-curing)luting composite system for the adhesive luting ofceramic and composite restorations.	Variolink Esthetic is a color-stable, adhesive lutingsystem for the permanent cementation of ceramicand composite resin restorations.
Variolink II may also be applied in the light-curingtechnique only (e.g. luting of veneers). For thispurpose, only the Variolink II Base is to be used.	Variolink Esthetic is offered in a light-curing version(Variolink Esthetic LC) and a dual-curing version(Variolink Esthetic DC).
Variolink II Try-in Pastes. Water-soluble glycerinepastes shades to match the cement and usedtemporarily before cementation to visualize the finalshade.	Variolink Esthetic also includes an accessoryproduct, Variolink Esthetic Try-in which are water-soluble glycerine pastes shaded to match theVariolink Esthetic cement and used temporarilybefore cementation to visualize the final shade.
Variolink II is available in 6 base shades and 2catalyst shades. The catalyst is available in differentviscosities. Variolink II is available in syringes. Baseand catalyst are hand-mixed.	Variolink Esthetic is available in 5 shades:Light +, Light, Neutral, Warm, Warm +Variolink Esthetic DC is available in one consistency.Variolink Esthetic LC is available in syringes.Variolink Esthetic DC is available in double-pushsyringes with mixing tips so the material is dispensedready-mixed.
Cool storage (2-8 °C/36-46 °F) is indicated for thecatalyst paste. Syringes should be closedimmediately after use. Exposure to light causespremature polymerization.	2-28 °C/36-82 °F for all items. Close VariolinkEshetic LC syringes immediately after use. Exposureto light causes premature polymerization.

Technological Characteristics and Testing Summary: The device has been tested and designed in accordance with ISO 4049:2009 Dentistry - Polymer-based restorative materials for film thickness, Depth of Cure, sensitivity to ambient light, working time, flexural strength, water sorption, solubility, and radiopacity. Biocompatibility testing has been assessed according EN ISO 10993-1:2009 and EN ISO 7405:2008. The device design, i.e. delivery form, and intended use of Variolink® Esthetic and the predicate device are the same.

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510(K) SUMMARY Variolink Esthetic

Image /page/5/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is blue and green, with the word "Ivoclar" in a large, bold font. Above the word "Ivoclar" are a series of green and blue squares. Below the word "Ivoclar" is the word "Vivadent" in a smaller, less bold font. The logo is simple and modern, and it is likely used to represent a company that specializes in dental products.

Guidance Document: This submission complies with the requirement of "Guid Industry and FDA Staff: Dental Composite Resin Devices - Premarket Notification innovation Submissions" dated October 26, 2005.

CONCLUSION: The above data and analysis demonstrates that Variolink® Esthetic is substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.