Bonding of direct composite, Polyglas® and compomer restorations .
Bonding of indirect laboratory-fabricated ceramic, Polyglas and composite . restorations (inlays, onlays, veneers and crowns)
0 Treatment of hypersensitive tooth regions

Device Description

iBond Total Etch is an improved light-component adhesive for use in adhesive restorative dentistry and was developed within the scope of the project IBTE on the base of an ethanol solution of light-activated, adhesive resins The material is characterized by the following properties in detail

The material has been developed for the adhesive bonding of plastic filling materials (e g ♥ composites, comporner, Polyglas ) to dental hard substance and laboratory-fabricated restorations (e g ceramics)
With IBOND Total Etch, priming, bonding and desensitizing can be done in one step .
Before using IBOND Total Etch, the dental hard substance is conditioned with iBOND Etch 35 Gel (etch&rinse)
In its unpolymenzed state, the adhesive matenal is workable smilar to current products Cross linking reaction is initiated with light curing (QTH, LED) devices customary in dental technology Cross-Iniking of the methacrylate monomers occurs very fast, ensurng reliable curing of the adheswe layer
Thus, a highly cross-linked material results, fully complying with the mechanical requirements for a dental adhesive matenal

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state quantitative acceptance criteria or a dedicated performance table for iBOND Total Etch. Instead, it relies on comparative evaluations and conformity to established standards for dental materials.

Acceptance Criteria Category	Description (as inferred)	Reported Device Performance
Biocompatibility	Meets requirements of EN ISO 10993-1.	Confirmed to meet DIN EN ISO 10993 standard. Cured adhesive did not show significant toxicological reaction. Benefit/risk-relation judged as positive.
Physical Properties	Equal to or better than current Heraeus and competitive products.	Results have shown equal or better properties of iBOND Total Etch compared to current Heraeus and various competitive products.
Clinical Performance	Exhibits claimed technical performance; potential undesirable clinical effects and risks are well controlled and acceptable. Positive risk-benefit ratio.	Concluded that the product can be expected to exhibit claimed technical performance, and potential undesirable clinical effects and risks are well controlled and acceptable when weighed against benefits in dentistry. Positive risk versus benefit ratio stated by the expert.
Safety	Application considered safe (risk analysis according to EN ISO 14971).	Risk analysis carried out according to DIN EN ISO 14971 showed that the application of iBOND Total Etch could be considered safe.
Regulatory Compliance	Meets Medical Device Directive 93/42/EEC and national European medical device legislation.	Meets all requirements relevant for dental adhesive material in accordance with the Medical Device Directive 93/42/EEC and national European medical device legislation. Evaluated to be effective and safe.

Sample Size for Test Set and Data Provenance:

The document does not specify a sample size for any "test set" in the context of an algorithmic or AI-based device. This document describes a traditional medical device (dental adhesive) and its evaluation.

There is no data provenance information (country of origin, retrospective/prospective) for a "test set" as this type of study design is not applicable to the evaluation described.

Number of Experts and Qualifications for Ground Truth:

The document mentions an "expert" for the clinical evaluation who states a positive risk-benefit ratio. However, it does not specify the number of experts used to establish ground truth or their specific qualifications (e.g., number of years of experience, specific medical specialty).

Adjudication Method for Test Set:

An adjudication method is not applicable to the evaluation described in this document, as it is not an AI/algorithmic device requiring consensus on diagnostic labels from a test set.

Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not conducted as this is not an AI-assisted device. The document describes a dental adhesive material.

Standalone (Algorithm Only) Performance Study:

A standalone performance study was not conducted as this is not an AI/algorithmic device.

Type of Ground Truth Used:

The "ground truth" for this device's evaluation is primarily based on:
* Biocompatibility testing results against established international standards (DIN EN ISO 10993).
* Laboratory-measured physical properties of the material compared to established products.
* Clinical evaluation based on scientific data and technical results, assessed for safety and effectiveness in its intended use, likely drawing upon existing literature and expert judgment.
* Risk analysis outcomes according to DIN EN ISO 14971.

Sample Size for Training Set:

The document does not mention a training set as this is not an AI/algorithmic device.

How Ground Truth for Training Set Was Established:

This information is not applicable as there is no training set for an AI model. The evaluation of this device relies on standard medical device testing and clinical evaluation processes, not machine learning model training.

Summary

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K083652 Heraeus

Summary of safety and effectiveness of the adhesive iBOND Total Etch (=IBTE) JAN 2 1 2009

Description and intended use of the medical device 1

The material has been developed for the adhesive bonding of plastic filling materials (e g ♥ composites, comporner, Polyglas ) to dental hard substance and laboratory-fabricated restorations (e g ceramics)
With IBOND Total Etch, priming, bonding and desensitizing can be done in one step .
Before using IBOND Total Etch, the dental hard substance is conditioned with iBOND Etch � 35 Gel (etch&rinse)

In its unpolymenzed state, the adhesive matenal is workable smilar to current products Cross linking reaction is initiated with light curing (QTH, LED) devices customary in dental technology Cross-Iniking of the methacrylate monomers occurs very fast, ensurng reliable curing of the adheswe layer

Thus, a highly cross-linked material results, fully complying with the mechanical requirements for a dental adhesive matenal

2 Indication list

Adhesive fixing of direct composite, Polyglas and compomer restorations .
Adhesive fixing of indirect laboratory-fabricated ceramic, Polygias and composite restorations ◆
Treatment of hypersensitive tooth regions .

3 Biocompatibility Evaluation

In accordance with the Medical Device Directive 93/42/EWG and national European medical device legislation, any medical device to be evaluated by the legal medical device manufacturer regarding its clinical performance and safety This includes an evaluation of biocompatibility in accordance with EN ISO 10993-1

The biological compatibility of the prototype IBTE was vertiled in accordance with the international standard The cured adhesive did not show a significant toxicological reaction

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Seite 2

The biocompatibility of iBond Total Eich in the aforementioned indication was documented in a brocompatibility evaluation report and the benefithsk-relation has been judged as positive

4 Physical properties

ıBond Total Etch was developed with focus to a simple and safe application The physical properties of Bond Total Elch were determined in comparison with current products The results have shown equal or better properties of iBond Total Etch to the current Heraeus and various competitive products

5 Clinical Evaluation

In accordance with the medical Device directive 93/42/EWG and national European medical device legislation, any medical device is requested to be evaluated by the legal medical device manufacturer regarding its clinical performance and safety This includes a clinical evaluation in accordance with MEDDEV 2 7 1 , which is intended to critically evaluate the clinical benefits of the medical device in comparison to its potential risks Therefore, any dinical evaluation is part of the compulsory risk management process according to EN ISO 14971, and critical findings must further be considered in the current risk management process of the medical device responsible for the evaluated device

On this background, the clinical evaluation was performed in order to comply with the current european medical device legislation, in particular with MEDDEV 2 7 1 This critical evaluation followed the procedures outlined in the corresponding clinical evaluation olan

iBond Total Eich is a light-cured single-component adhesive, which is generally classified as a class lla medical device under the Medical Davice Directive 93/42/EEC The material has been developed for the adheswe bonding of plastic filling matenals (e g composites comporner, Polyglas ) to dental hard substance and laboratory-fabricated restorations (e g ceramics), intended for long-term application

Considering the evaluated scientific data and technical results for iBond Total Etch it is concluded that the product can be expected to exhibit the claimed technical performance and that potential undesirable clinical effects and risks seem well controlled and acceptable, when weighed against their benefits in dentistry Therefore, a positive nsk versus benefit ratio can be stated by the expert for iBond Total Etch, provided that the product applied in accordance with its intended use as outlined in the manufacturer s instruction for use

The clinical evaluation report was prepared in accordance with MEDDEV 2 7 1 and followed the provisions of the corresponding clinical evaluation plan

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Seite 3

6 Summanzed Evaluation

The risk potential of the developed adheswe iBond Total Etch was proved with the laboratory prototype and a prototype from production All properties of the prototype were verthed successfully The risk potential of the developed material iBond Total Etch was proven with the prototype from laboratory and production

The broked compatibility of the adhesive material was investigated to evaluate the toxicological risk A certified laboratory has confirmed that the product iBond Total Etch meets the requirements of the DIN EN ISO 10993 standard The results were discussed in a Biocompatibility Evaluation Report and the benefit/risk-relation has been judged as positive

The physical properties of Bond Total Etch were determined in companson with current products The results have shown equal or better properties of (Bond Total Etch to the current Heraeus and various competitive products

Based on the results of the clinical evaluation report it is concluded that the product can be expected to exhibit the claimed technical performance and that potential undestrable clinical effects and nsks seem well controlled and acceptable when weighted against their benefits in dentistry

The risk analysis (according to DIN EN ISO 14971) was carried out for the composition of the protobype (Bond Total Elch and showed that the application of lBond Total Elch could be considered to be safe

iBond Total Eich meets all requirements relevant for dental achesive material in accordance with the Medical Device directive 93/42/EEC and national European medical device legslation Based on the actual facts (Bond Total Etch could be evaluated to be effective and safe with its intended use as outlined in the manufacturer s instruction for use

Wehrheim, 24 09 2008

harus hope

Dr Marcus Hoffmann

14 Annegrete Wegner

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three lines representing the agency's services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Heraeus Kulzer. GmbH C/o Ms Cheryl V Zimmerman Director, Regulatory Affairs Heraeus Kulzer, Incorporated 300 Heraeus Way South Bend, Indiana 46614-2517

JAN 21 2009

K083652 Re Trade/Device Name IBond Total Etch Regulation Number 21 CFR 872 3200 Regulation Name Resin Tooth Bonding Agent Regulatory Class II Product Code KLE and LBH Dated December 8, 2008 Received December 9 2008

Dear Ms Zimmerman

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 1eclassified 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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Ms Zimmerman

Please be advised that I'DA s issuance of a substantial equivalence determination does not mean that IDA has made a determination that your device complies with other requirements of the Act of any Federal statutes and regulations administered by other Federal agencies You must comply with all the Act's requirements, including, but not limited to 1egistration and listing (21 CFR Patt 807), labeling (21 CFR Part 801), good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820), and if applicable, the electronic product radiation control provisions 531-542 of the Act), 21 CFR 1000-1050

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your dovice to proceed to the market

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Pat 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Bromettic 's (OSB s) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index html

Sincerely yours,

Anthony V. Araton for

Ginette Y Michaud, M D Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

て。

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Indications for Use KOR 465 L

510(k) Number (if known)

Device Name ____ BOND TOTAL ETCH_

Indications for Use

Bonding of direct composite, Polyglas® and compomer restorations .
Bonding of indirect laboratory-fabricated ceramic, Polyglas and composite . restorations (inlays, onlays, veneers and crowns)
0 Treatment of hypersensitive tooth regions

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumer

Page 1 of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number K083652

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.