(107 days)
Not Found
No
The summary describes a dental bonding agent and its intended uses, focusing on material properties and bonding strength. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a dental adhesive used for bonding restorations and orthodontic brackets, which is a structural or cosmetic function rather than a therapeutic one (treating or alleviating a disease or condition).
No
This device is a dental adhesive system used for bonding restorations and orthodontic brackets, not for diagnosing medical conditions.
No
The device description clearly indicates it is a "onebottle adhesive system," which is a physical product (a liquid or gel) used for dental bonding, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes bonding dental restorations and orthodontic brackets to tooth structure. This is a direct application to the patient's body for therapeutic or restorative purposes.
- Device Description: The description reinforces the use as a dental adhesive for bonding various materials to teeth.
- Anatomical Site: The anatomical site is tooth structure (enamel and dentine), which is part of the living organism.
- Lack of IVD Characteristics: There is no mention of analyzing samples taken from the human body (like blood, urine, tissue) to provide information about a physiological state, disease, or condition.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for medical conditions. This device is a material applied to the body for a restorative purpose.
N/A
Intended Use / Indications for Use
Bonding all classes of direct composite restorations as well as for indirect procedures involving metal, porcelain, or composite crowns, inlays or onlays. The Angelus products multi-purpose systems also bond amalgam and self-cure composite can be used to bond orthodontic brackets to enamel.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
The Fusion Single Link by Angelus is a versatile system for dental bonding. It is a onebottle adhesive system, indicated for restorations, adhesive cementation of indirect restorations (cast metal, porcelain and composite resin veneers) and intraradicular posts (cast metal and prefabricated in metal or fiber). It can also be used for the bonding of orthodontic brackets, and for the repair of porcelain restorations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth structure (enamel and dentine)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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)
Based on performance data according the ISO/TS 11405: 2003, it was found that the average strength and average resistance of the two devices are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Film thickness Enamel adhesive layer (µm): 8.2(2.40)
Dentin adhesive layer (µm): 8.4(2.6)
Application time Total time 60 second
Light cure time 12 seconds
Bond to Dentin 37 MPa
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image shows the logo for Angelus. The logo consists of a black circle with a white triangle inside, followed by the word "angelus" in black lowercase letters. Below the word "angelus" is some smaller text that is difficult to read.
CONFIDENTIAL
SECTION 6
510(k) Summary
Proprietary Name K Number Date Prepared
Fusion Single Link K132923 December 3, 2013
Submitter
Angelus Industria de Productos Odontologicos Waldir Landgraf, 101 Londrina, Brazil 86031-3200
Telephone: +55 43 2101 3200
Official Contact
Tara Conrad TechLink International Consulting 18851 NE 29th Avenue Suite 720 Aventura, FL 33180 TEL- (305) 377-0077
Common Name: Trade Name: Classification: Product Code: Classification Panel: Requlation Numbers: Substantial Equivalence:
Resin Tooth Bonding Agent Fusion Single Link Class II KLE Dental 21 CFR 872.3200 K962785 3M Dent System (Single Bond) by 3M Company
Description of Proposed Device
The Fusion Single Link by Angelus is a versatile system for dental bonding. It is a onebottle adhesive system, indicated for restorations, adhesive cementation of indirect restorations (cast metal, porcelain and composite resin veneers) and intraradicular posts (cast metal and prefabricated in metal or fiber). It can also be used for the bonding of orthodontic brackets, and for the repair of porcelain restorations.
Indications for Use
Bonding all classes of direct composite restorations as well as for indirect procedures involving metal, porcelain, or composite crowns, inlays or onlays. The Angelus products multi-purpose systems also bond amalgam and self-cure composite can be used to bond orthodontic brackets to enamel.
1
Image /page/1/Picture/0 description: The image shows the logo for Angelus. The logo consists of a circular icon with a stylized "A" inside, followed by the word "angelus" in a bold, sans-serif font. Below the word "angelus" are smaller words that are difficult to read.
Device Comparison Table
| Subject Device | Predicate Device | |
|---|---|---|
| Fusion Single Link by Angelus | K962785 3M Dent System (Single | |
| Bond) by 3M Company | ||
| Indications for use | Bonding all classes of direct | |
| composite restorations as well as | ||
| for indirect procedures involving | ||
| metal, porcelain, or composite | ||
| enamel. | Bonding all classes of direct | |
| composite restorations as well as | ||
| for Indirect procedures involving | ||
| metal, porcelain, or composite | ||
| crowns, inlays or onlays. The 3m | ||
| Dent System also bonds | ||
| amalgam and self-cure composite | ||
| can be used to bond orthodontic | ||
| brackets to enamel and root | ||
| desensitization | ||
| Delivery System | Unit Dose, Vial | Unit Dose, Vial |
| Material | Light Cure | Light Cure |
| Product Type | Adhesive | Adhesive |
| Film thickness | Enamel adhesive layer (µm): | |
| 8.2(2.40) | Enamel adhesive layer (µm): | |
| 6.40(2.80) | ||
| Dentin adhesive layer (µm): | ||
| 8.4(2.6) | Dentin adhesive layer (µm): | |
| 4.22(1.25) | ||
| Application time | Total time 60 second | |
| Light cure time 12 seconds | Total time 57 second | |
| Light cure time 10 seconds | ||
| Bond to Dentin | 37 MPa | 45 MPa |
Substantial Equivalence
The predicate and subject devices are substantially equivalent because they are both adhesive systems. They have the same intended use and similar materials. They both utilize materials that will polymerize upon exposure to visible light from a dental curing light. The systems act as both a primer and an adhesive.
Biocompatibility
Single Link has the same composition and applications as its predicate. This product is for permanent contact with tissue, bone and dentin.
Performance Data
Based on performance data according the ISO/TS 11405: 2003, it was found that the average strength and average resistance of the two devices are substantially equivalent.
ISO/TS 11405: 2003- Dental materials -- testing of adhesion to tooth structure
ISO 11405:2003 gives guidance on substrate selection, storage and handling as well as essential characteristics of different test methods for quality testing of the adhesive bond between restorative dental materials and tooth structure, i.e. enamel and dentine. It specifies two bond strength measurements tests (tensile and shear), a test for measurement of marginal gaps around fillings and a microleakage test, as well as giving recommendations on clinical usage tests for such materials. It also presents
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Image /page/2/Picture/0 description: The image shows the logo for Angelus Computer Technologies. The logo consists of a black circle with a white triangle inside, followed by the word "angelus" in a lowercase, sans-serif font. Below the word "angelus" are the words "computer and technologies" in a smaller, sans-serif font.
some specific test methods for bond strength measurements.
Conclusion
Based on chemical composition, testing, and indications for use, Angelus has concluded that he subject and predicate devices are substantially equivalent that the subject device does not raise any safety or effectiveness concerns. Therefore the devices have been found to be substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 3, 2014
TechLink International Consulting Ms. Tara Conrad Regulatory Affairs Manager 18851 NE 29TH Avenue Suite 720 Aventura, FL 33180
Re: K132923
Trade/Device Name: Fusion Single Link Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: October 9, 2013 Received: October 10, 2013
Dear Ms. Conrad:
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.
4
Page 2 - Ms. Conrad
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mary-S. Runner -S
Erin I. Keith. M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
Device Name: Fusion Single Link
510(k) Number: K132923
Indications for Use:
Bonding all classes of direct composite restorations as well as for indirect procedures involving metal, porcelain, or composite crowns, inlays or onlays. The Angelus products multi-purpose systems also bond amalgam and self-cure composite can be used to bond orthodontic brackets to enamel.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
- Mary S. Runner -5 2014.01.03 12:36:50 -05:00