IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF

{0}------------------------------------------------ K1232-78 Taeus # 510(k) Summary according to 21 CFR 807.92(c) 510(k) summary of safety and effectiveness information for iBond Seff Etch (new formulation) | Submitter Information: | | |-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Heraeus Kulzer, LLC | | Address | 300 Heraeus Way<br>South Bend, IN 46614 | | Phone Number | (574) 299-5421 | | Fax Number | (574) 291-0080 | | Establishment Registration Number | 1925223 | | Name of Contact Person | Jamie Mearna | | Date Prepared | December 3, 2012 | | Name of Device: | iBond Self Etch | | Trade or Proprietary Name | iBond Self Etch | | Common or Usual Name | Resin Tooth Bonding Agent | | Classification Name | Dental KLE | | Device Classification | Class II | | Classification Panel: | 76 Dental | | Regulation: | 21 CFR 872.3200 | | Product code (s): | KLE | | Legally marketed devices(s) to which<br>equivalence is claimed: | HK Bond K063062 | | Reason for 510(k) Submission: | This submission reports a modification to HK<br>Bond K063062 regarding the addition of a<br>stabilizer, change in rheological additive and<br>storage requirements. | | Device Description: | iBond Self Etch(new formulation is an<br>acetone/water-based formulation of light<br>activated methylacrylate resins. | | Intended use of the device: | See indications for use below. | | Indications for use: | iBond Self Etch (new formulation) it intended<br>for use by dental professionals, for the<br>bonding of direct light-cured composite<br>restorations (including Polyglas® and<br>copomers), bonding of indirect restorations in<br>combination with a light curing luting cement;<br>porcelain, polyglas®, and composite<br>restorations (inlays, onlays, veneers crowns)<br>and sealing hypersensitive areas of teeth. | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "Heraeus" in a stylized font. The letters are outlined with a double border, giving them a hollow appearance. The text is presented in a horizontal arrangement, with each letter clearly distinguishable despite the decorative outline. ## Summary of the Technological Characteristics of the New Device Compared to the predicate Device HK Bond K063062: The formula of the proven all-in-one adhesive has been refined. The modifications include the addition of a stabilizer the exchange of a rheological additive. The enhanced iBOND Self Etch new formulation is now conveniently useable and storable at room temperature (up to 25°C). The adhesive no longer requires shaking. The product fulfills the internal specification. The basic fundamental scientific technology remains the same as well as the indications for use. | | CLEARED iBOND Self Etch | NEW iBOND Self Etch | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | | (BHT)- K063062 | (ISEA-EC) | | Content of BHT | 750 ppm | Same | | Indications for Use | iBOND Self Etch is used for<br>bonding of direct light-cured<br>composite restorations<br>(including Polyglas® and<br>copomers), bonding of<br>indirect restorations in<br>combination with a light-<br>curing luting cement;<br>porcelain, Polyglas®, and<br>composite restorations<br>(inlays, onlays, veneers,<br>crowns) and sealing<br>hypersensitive areas of<br>teeth. | Same | | Visual Appearance | Yellowish liquid,<br>homogeneous, without<br>sediment | Same | | pH | <2,00 | Same | | Refractive index | 1,421-1,426 | Same | | Application | Application in 1 layer | Same | | Dwell time | 20s | Same | | Curing time | 20s | Same | | Compatibility | Compatible with direct light<br>cured composite, light cured<br>luting cement, porcelain | Same | ### Similarities as Compared to Predicate: {2}------------------------------------------------ |--|--|--| | CHARLERS CREEN LE LE LE SE MERICLE CARRIES CLAND SERVICE | A S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S<br>Polvelas®<br>and composite | COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTIO | |----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | restorations<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | Note: For formulation similarities as compared to predicate, please see section 11 of this submission. #### Differences as Compared to Predicate: | | CLEARED iBOND Self Etch | NEW iBOND Self Etch | |---------------------|-------------------------|---------------------------| | | <b>(BHT)-K063062</b> | <b>(ISEA-EC)</b> | | Shear Bond Strength | >15 MPa | ≥20 MPa | | Storage condition | Refrigeration required | No refrigeration required | | Handling | Shaking necessary | No shaking necessary | Note: For formulation differences as compared to predicate, please see section 11 of this submission. #### Results Summary: The biological compatibility of iBOND Self Etch was verified in accordance with the international standard EN ISO 10993. The medical devices iBOND Self Etch and new formulation were extracted with hydrophilic and lipophilic extraction medium according to EN ISO 10993-12. Leachable compounds detected in n-hexane, isopropanole and saline extracts are considered covered by the toxicological tests performed with iBOND Self Etch. Considering the low exposure of the patient and animal welfare requirements, no in vivo toxicity studies were performed with the uncured or cured material. The biocompatibility of iBOND Self Etch _new formulation in the aforementioned indication is documented and the benefit/risk-relation has to be judged as positive. An allergenic potential in predisposed persons cannot be excluded completely due to the presence of monomers such as acrylates and methacrylates. #### Conclusions Drawn From Non-Clinical and Clinical Data: The refined formula of the proven all-in-one adhesive is substantially equivalent to cleared iBOND Self Etch. A biocompatibility evaluation has been performed by a toxicologist for iBOND Self Etch _ new formulation. It was confirmed that the product meets the requirements of ISO 10993 and it is concluded that the safety of iBOND Self Etch __new formulation is equivalent to that of the predicate device. The risk analysis acc. ISO 14791 was carried out for iBOND Self Etch _new formulation. It is concluded that safety of iBOND Self Etch _new formulation for the intended use is substantially equivalent to the predicate device. iBOND Self Etch_new formulation and the predicate Page 3 of 4 {3}------------------------------------------------ HERAEUS formula have the same indication for use, warnings and contraindications. When used in accordance with the instruction for use, by qualified personnel, iBOND Self Etch _new formulation is safe and effective, as indicated for the intended use. . . . . {4}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized emblem with three curved lines, resembling a person with outstretched arms, positioned to the right. Encircling the emblem is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 #### December 7, 2012 Ms. Jamie Mearna Associate Quality Assurance & Regulatory Manager Heraeus Kulzer, Limited Liability Company 300 Heraeus Way SOUTH BEND IN 46614 Re: K123278 Trade/Device Name: iBond Self Etch Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 25, 2012 Received: November 19, 2012 Dear Ms. Mearna: 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. {5}------------------------------------------------ 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 or any I vature 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 Or ice-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 n you desire specific advisiboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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. Sincerely yours, Kwame O. Ulmer Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): _ K (23279 Device Name: iBond Self Etch Indications for Use: iBond Self Etch is an acetone/water-based formulation of light-activated methylacrylate resins. iBond Self Etch is used for bonding of direct light-cured composite restorations (including Polyglas and copomers), bonding of indirect restorations in combination with a light-curing luting cement; porcelain, Polyglas®, and composite restorations (inlays, onlays, veneers, crowns) and sealing hypersensitive areas of teeth. Over-The-Counter Use Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) i 2012.12.07 Susan Runner DDS, MA 15:06:19 -05'00' (Division Sign-Off) (UNIsion Sign-On) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page _1_ of . 510(k) Number: