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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Fusion Single Link device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Predicate Device K962785 3M Dent System)	Reported Device Performance (Fusion Single Link)
Film thickness
Enamel adhesive layer	6.40 (2.80) µm	8.2 (2.40) µm
Dentin adhesive layer	4.22 (1.25) µm	8.4 (2.6) µm
Application Time	57 seconds	60 seconds
Light cure time	10 seconds	12 seconds
Bond to Dentin	45 MPa	37 MPa
Indications for Use	Bonding all classes of direct composite restorations, indirect procedures (metal, porcelain, composite crowns, inlays, onlays), amalgam, self-cure composite, orthodontic brackets to enamel, root desensitization.	Bonding all classes of direct composite restorations, indirect procedures (metal, porcelain, composite crowns, inlays, onlays), amalgam, self-cure composite, orthodontic brackets to enamel.

Note: The document states that "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." This implies that despite some numerical differences, the overall performance is considered comparable for the purpose of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set. It mentions "performance data" according to ISO/TS 11405: 2003, but not specific numbers of samples or cases.

The data provenance is not specified beyond being "performance data according the ISO/TS 11405: 2003". It doesn't indicate country of origin or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The study relies on standardized testing methods (ISO/TS 11405: 2003) to measure bond strength and other properties, rather than expert-established ground truth in a clinical or imaging context.

4. Adjudication Method for the Test Set

Not applicable as the study uses objective measurements based on ISO/TS 11405: 2003, not expert review or consensus for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the performance of the new device to a predicate device based on material properties and bond strength, not on clinical interpretation or reading by human experts.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to the device described. The device is a dental adhesive, not an algorithm or AI system. The performance data presented refers to the physical and chemical properties of the adhesive itself.

7. Type of Ground Truth Used

The "ground truth" for this study is based on objective measurements of material properties and bond strength as defined by the ISO/TS 11405: 2003 standard. This standard provides guidelines for testing adhesion to tooth structure, including tensile and shear bond strength measurements.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set" in that sense. The study involves laboratory testing of material properties.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as points 8 explains.

Summary

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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

Indications for Use

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Device Comparison Table

	Subject Device	Predicate Device
	Fusion Single Link by Angelus	K962785 3M Dent System (SingleBond) by 3M Company
Indications for use	Bonding all classes of directcomposite restorations as well asfor indirect procedures involvingmetal, porcelain, or compositeenamel.	Bonding all classes of directcomposite restorations as well asfor Indirect procedures involvingmetal, porcelain, or compositecrowns, inlays or onlays. The 3mDent System also bondsamalgam and self-cure compositecan be used to bond orthodonticbrackets to enamel and rootdesensitization
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 secondLight cure time 12 seconds	Total time 57 secondLight 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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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.

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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

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Indications for Use Statement

Device Name: Fusion Single Link

510(k) Number: K132923

Indications for Use:

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

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.