(43 days)
Not Found
Not Found
No
The document describes a chemical adhesive material and its physical properties and clinical performance, with no mention of AI or ML.
No
Explanation: The device is described as an adhesive for bonding dental filling materials and restorations, and for treating hypersensitive tooth regions. While it performs a function that aids in dental health, it's not a therapeutic device in the sense of directly treating a disease or condition. It acts as a bonding agent and aids in desensitizing, which are supportive functions for restorative dental procedures.
No
This device is a dental adhesive used for bonding restorative materials and treating hypersensitive tooth regions. It is not described as being used to diagnose a condition or disease.
No
The device description clearly describes a chemical adhesive material ("ethanol solution of light-activated, adhesive resins") that undergoes a physical change (cross-linking reaction initiated by light curing). This is a physical/chemical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for bonding dental restorations and treating hypersensitive tooth regions. This is a therapeutic and restorative application, not a diagnostic one.
- Device Description: The device is described as a light-curing adhesive for use in restorative dentistry. It focuses on the material properties and how it functions to bond materials to teeth.
- Anatomical Site: The anatomical site is dental hard substance and tooth regions, which are within the body, not samples taken from the body for in vitro testing.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens derived from the human body to provide information for diagnostic purposes.
IVD devices are used to perform tests on samples (like blood, urine, tissue) taken from the body to diagnose diseases or conditions. This device is applied to the body for treatment and restoration.
N/A
Intended Use / 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)
- Treatment of hypersensitive tooth regions
Product codes
KLE, LBH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dental hard substance / Tooth regions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental technology
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The biocompatibility of iBond Total Etch was documented 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 comparison with current products. The results have shown equal or better properties of iBond Total Etch to the current Heraeus and various competitive products.
A clinical evaluation was performed in order to comply with the current European medical device legislation, in particular with MEDDEV 2 7 1. 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.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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
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
1
Image /page/1/Picture/0 description: The image shows the word "Heraeus" in a stylized font. The letters are outlined with a rough, textured edge, giving them a slightly distressed or vintage appearance. The word is presented in a single line and appears to be the focus of the image.
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
2
Image /page/2/Picture/0 description: The image shows the word "Heraeus" in a stylized font. The letters are outlined in black and filled with a textured pattern, giving them a three-dimensional appearance. The word is presented in a slightly curved or arched arrangement, adding a dynamic element to the design. The overall effect is a visually striking representation of the brand name.
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
IA
14 Annegrete Wegner
3
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
4
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。
5
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