VITA VIONIC® Bond is a two-component glue, mainly composed of acrylate polymers based on methyl methacrylate and used to fix artificial teeth in the milled denture base. VITA VIONIC® component I comes in a glass jar with a screw top lid and VITA VIONIC® Bond component II comes in a glass bottle with a screw top cap. Component II is mixed into component I by stirring until no streaks are visible. A thin film is then applied to all Bonding surfaces and then the artificial teeth are placed into the denture base and VITA VIONIC® Bond is allowed to cure. Comes in one, colorless shade. This product is provided non-sterile.

AI/ML Overview

This document describes the non-clinical performance testing for VITA VIONIC® Bond, a two-component glue for fixing artificial teeth.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard & Section)	Reported Device Performance
DIN EN ISO 20795-1:2013 - Dentistry - Base polymers - Part 1: Denture base polymers (ISO 20795-1:2013)	The device was evaluated according to this standard. Specifically, the device was tested under section 8.7 "Bonding to synthetic polymer teeth" and section 8.9: Water solubility and water sorption. The bench test results allowed the manufacturer to conclude that VITA VIONIC® Bond is substantially equivalent to the predicate device for its intended use. (Specific numerical performance values are not provided in this summary.)
ISO 10993-1:2009 - Biological evaluation of medical devices	Biocompatibility assessment performed. Tests conducted for cytotoxicity, sensitization, irritation and intracutaneous reactivity, and genotoxicity. Results showed no cytotoxic or genotoxic results, and irritation and sensitization risks were evaluated as low. This assessment supports the biocompatibility of the device.
ISO 7405:2004 (or 2008 as cited in Biocompatibility section) – Dentistry – Evaluation of biocompatibility of medical devices	(Same as ISO 10993-1:2009) Biocompatibility assessment performed. Tests conducted for cytotoxicity, sensitization, irritation and intracutaneous reactivity, and genotoxicity. Results showed no cytotoxic or genotoxic results, and irritation and sensitization risks were evaluated as low. This assessment supports the biocompatibility of the device.
Chemical Analysis (Residual monomer content)	Residual monomer content was found to be below the limit values.

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not explicitly stated for each test. The document refers to "bench test results" and "biocompatibility tests."
Data Provenance: The testing was conducted by or on behalf of VITA Zahnfabrik H. Rauter GmbH Co. which is located in Germany. These are non-clinical (bench and lab) studies.

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

This information is not applicable as the described testing is non-clinical performance evaluation, not expert-based assessment of clinical images or data. The "ground truth" for these tests are the established scientific and engineering principles and specifications defined by the respective ISO/DIN standards.

4. Adjudication Method for the Test Set

This information is not applicable for non-clinical performance tests. Outcomes are typically based on objective measurements against predefined criteria/limits outlined in the standards.

5. 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

This information is not applicable. This submission pertains to a physical dental bonding agent, not an AI-powered diagnostic device or software. No MRMC study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This submission pertains to a physical dental bonding agent, not an algorithm or AI.

7. The Type of Ground Truth Used

For the non-clinical performance testing (e.g., bonding strength, water absorption/solubility, residual monomer content), the ground truth is established by the specifications and methodology defined in the referenced international standards (DIN EN ISO 20795-1) and chemical analysis techniques.
For biocompatibility, the ground truth is established by the results of in vitro and in vivo (pre-clinical) biological tests performed according to ISO 10993-1 and ISO 7405, which assess endpoints like cytotoxicity, genotoxicity, irritation, and sensitization against accepted safety thresholds.

8. The Sample Size for the Training Set

This information is not applicable. This submission pertains to a physical dental bonding agent. There is no "training set" in the context of machine learning for this device.

9. How the Ground Truth for the Training Set was Established

This information is not applicable. As there is no training set, there is no ground truth for a training set.

Summary

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January 29, 2020

VITA Zanhnfabrik H. Rauter GmbH Co. % Lindsay Tilton Regulatory Affairs & Compliance (Consultant) VITA North America 22705 Savi Ranch Parkway, Sutie 100 Yorba Linda. California 92887

Re: K191926

Trade/Device Name: VITA VIONIC Bond Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: December 20, 2019 Received: December 30, 2019

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 mediation-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)

K191926

Device Name VITA VIONIC Bond

Indications for Use (Describe)

VITA VIONIC Bond is used to fix custom-fit prosthetic teeth in appropriately milled cavities of prosthetic bases.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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K191926 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 SystemsPhone (+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) 699-9091E-mail: ltilton@vitanorthamerica.com
Date Prepared	January 24, 2020

Trade/Device Name VITA VIONIC® Bond
י Classification Name Denture relining, repairing, or rebasing resin
. Regulation Number 21 CFR 872.3760
Product Code EBI

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Predicate and Reference Predicate Devices

lvoBase CAD Bond, and Modelling Liquid – K151142 – Primary Predicate Device

Tokuyama Curegrace – K170549 – Reference Predicate Device

Device Description

This product is provided non-sterile.

Indications for use

VITA VIONIC® Bond is used to fix custom-fit prosthetic teeth in appropriately milled cavities of prosthetic bases.

Material Composition

VITA VIONIC® Bond is mainly composed of acrylate polymers based on methyl methacylate (MMA)

Non-Clinical Performance Testing

VITA VIONIC® Bond was evaluated according to the following FDA recognized standards:

. DIN EN ISO 20795-1:2013 - Dentistry - Base polymers - Part 1: Denture base polymers (ISO 20795-1:2013)
- o This standard mainly refers to the requirements for a denture base. VITA VIONIC® Bond, bonds the artificial teeth to the denture base, which is tested under section 8.7 "Bonding to synthetic polymer teeth"
- Section 8.9: Water solubility and water sorption
ISO 10993-1:2009 - Biological evaluation of medical devices
I ISO 7405:2004 – Dentistry – Evaluation of biocompatibility of medical devices
. A Chemical Analysis was conducted on VITA VIONIC® Bond and the Residual monomer content were found to be below the limit values.

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Bench test results allowed us to conclude that VITA VIONIC® Bond is substantially equivalent to the predicate device for its intended use.

Biocompatibility

A biocompatibility assessment was performed on VITA VIONIC® Bond 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 VIONIC® Bond is biocompatible and concludes that the device is substantially equivalent to the predicate device for its intended use based on the following:

Biocompatibility tests were conducted on VITA VIONIC Bond for cytotoxicity, sensitization, irritation and intracutaneous reactivity, and genotoxicity.

I Cytotoxicity and genotoxicity and the results showed no cytotoxic or genotoxic results
. Irritation and sensitization risks were evaluated and found to be low

Clinical Performance Data

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

	Subject Device	Primary PredicateDevice	Reference PredicateDevice
Device Name	VITA VIONIC® Bond	IvoBase Bond andModelling Liquid	Tokuyama CureGrace
Device Classification	Denture relining,repairing, orrebasing resin	Denture relining,repairing, orrebasing resin	Denture relining,repairing, orrebasing resin
Product Code	EBI	EBI	EBI,EBG
Indication for use	Used to fix custom-fit prosthetic teethin appropriatelymilled cavities ofprosthetic bases	For the fabricationof removabledentures, e.g.:-partial andcomplete denture	An acrylic resin usedin a variety ofdental applicationsuch as:-Temporary inlay,

Comparison to Predicate Devices

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		prosthetics	crowns and bridges
	Hybrid dentureprosthetics		-Repair of broken orcracked dentures
	-Combined dentureprosthetics		-Denture borderextension
	-Mouth guards		-Replacement oflost denture teeth
	-Implant-supporteddenture prosthetics		-Adjustment ofocclusal height ofresin teeth
Components	Liquid and Liquid	Powder and Liquid	Powder and Liquid
Principle ofoperation	Cured by chemicalpolymerizationreaction startingwith mixing theliquid and liquidcomponent. (Self-curing)	Cured by chemicalpolymerizationreaction startingwith mixing thepowder and liquidcomponent. (Self-curing)	Cured by chemicalpolymerizationreaction startingwith mixing thepowder and liquidcomponent. (Self-curing)

Conclusion

Information provided in this application demonstrates that VITA VIONIC® Bond is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.