(92 days)
Not Found
Not Found
No
The 510(k) summary describes a dental bonding agent and primer, which are chemical materials used in restorative dentistry. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The device description and performance study sections are also marked as "Not Found," further indicating a lack of information related to AI/ML components.
No.
The device is used for bonding and sealing dental materials and surfaces, which is restorative and preventive, rather than treating a disease or condition that alleviates or cures.
No
The device description focuses on bonding, sealing, and cementation of dental restorations and materials, which are therapeutic and restorative functions, not diagnostic ones.
No
The device description is not found, but the intended use clearly describes a bonding agent and ceramic primer, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The iBond Universal System and iBond Ceramic Primer are used for bonding and sealing dental restorations and tooth structures. They are applied directly to the tooth and surrounding areas.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples taken from the patient. The device's function is entirely related to the physical and chemical bonding of materials within the oral cavity.
Therefore, the intended use and device description clearly indicate that this is a dental restorative and bonding system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The iBond Universal System consists of iBond Universal bonding agent and iBond Universal Ceramic Primer. The iBond Universal indications are: Bonding of direct restoration for all cavity classes (Black) using light curing, dual curing or self-curing methacrylate based composites/compomers, Bonding of light curing dual curing or selfcuring core build up materials, sealing of hypersensitive tooth areas, sealing of cavities prior to amalgam restorations, bonding of fissure sealants, sealing of cavities and core preparations prior to temporary cementation of indirect restorations(according to the immediate dentin sealing technique), cementation of indirect restorations with light curing dual-curing or self-curing adhesive resin cements, intraoral repair of composite and compomer restorations, porcelain fused to metal, all ceramic as well as metal restorations.
The iBond Ceramic Primer indications are; surface conditioning of silicate/glass ceramic, specifically for the fixation of indirect restorations with luting composites, for intraoral repair of ceramic veneerings, as well as full ceramic restorations.
Product codes
KLE, EBF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2015
Heraeus Kulzer, LLC, Mitsui Chemicals Group Ms. Jamie L. Cleveland Associate Quality Assurance & Regulatory Affairs Manager 3001 Heraeus Way South Bend, IN 46614
Re: K150933
Trade/Device Name: iBond Universal and iBond Ceramic Primer Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE, EBF Dated: March 10, 2015 Received: April 8, 2015
Dear Ms. Cleveland:
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. Isting 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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Page 2 - Ms. Jamie L. Cleveland
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tina
Kiang -S
for 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
Enclosure
2
Indications for Use
510(k) Number (if known): K150933
Device Name: iBond Universal & iBond Ceramic Primer
Indications for Use:
The iBond Universal System consists of iBond Universal bonding agent and iBond Universal Ceramic Primer. The iBond Universal indications are: Bonding of direct restoration for all cavity classes (Black) using light curing, dual curing or self-curing methacrylate based composites/compomers, Bonding of light curing dual curing or selfcuring core build up materials, sealing of hypersensitive tooth areas, sealing of cavities prior to amalgam restorations, bonding of fissure sealants, sealing of cavities and core preparations prior to temporary cementation of indirect restorations(according to the immediate dentin sealing technique), cementation of indirect restorations with light curing dual-curing or self-curing adhesive resin cements, intraoral repair of composite and compomer restorations, porcelain fused to metal, all ceramic as well as metal restorations.
The iBond Ceramic Primer indications are; surface conditioning of silicate/glass ceramic, specifically for the fixation of indirect restorations with luting composites, for intraoral repair of ceramic veneerings, as well as full ceramic restorations.
Prescription Use Over-The-Counter Use x AND/OR (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)
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