Adhesive system, light curable both with halogen and LED Light, for brackets cementation. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally.

AI/ML Overview

The provided document (K072978) is a 510(k) summary for a dental adhesive system (Tender Ortho Bond - Ena Bond - Ena Etch). This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing that adheres to recognized standards. It does not contain details of a clinical study or AI performance evaluation as requested in the prompt.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment, specifically in the context of an AI device and clinical study, cannot be extracted from this document.

However, I can provide information based on what is available in the document regarding the device's performance evaluation against a standard.

1. Table of Acceptance Criteria and Reported Device Performance

The document references "ISO 4049:2000 Dentistry - Polymer - Based Filling, Restorative and Luting materials" as the standard followed for evaluating the device. While the exact acceptance criteria from ISO 4049:2000 are not explicitly detailed in the provided text, the submission states that the standard was followed. The implied "reported device performance" is that the device met the requirements of this standard for its intended use, otherwise, substantial equivalence would not have been granted.

Acceptance Criterion (from ISO 4049:2000 - Implied)	Reported Device Performance
Adhesion/Bond Strength (for luting orthodontic brackets)	Complied with ISO 4049:2000 requirements for polymer-based luting materials.
Polymerization characteristics (e.g., degree of cure, working time)	Complied with ISO 4049:2000 requirements.
Biocompatibility (e.g., cytotoxicity)	Cytotoxicity tests appear in Appendix III (details not provided in this extract), implying satisfactory results.
Other physical/chemical properties as per ISO 4049:2000	Complied with ISO 4049:2000 requirements.

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

This document does not describe a "test set" in the context of a clinical study or AI evaluation. The performance evaluation would have been conducted on laboratory samples according to the specifications of ISO 4049:2000. No information on sample sizes for these lab tests or data provenance (country of origin, retrospective/prospective) is provided in the publicly available summary.

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

Not applicable. This document does not describe a study involving expert-established ground truth for a test set. The validation is based on adherence to an engineering standard (ISO 4049:2000).

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or expert adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not mention an MRMC study or any comparison of human readers with or without AI assistance. The device is a dental adhesive, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. The device is a dental adhesive. This concept is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this medical device submission is compliance with the ISO 4049:2000 standard for "Dentistry - Polymer-Based Filling, Restorative and Luting materials." This standard dictates the methods and criteria for evaluating the physical, chemical, and biological properties of such materials. The specific tests (e.g., bond strength, cytotoxicity) described within the standard would serve as the "ground truth" for performance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device, so there is no training set in that context. The "training set" for the device's development would refer to the materials and formulations developed and refined prior to final testing, but no specific sample sizes for this are provided in the regulatory summary.

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

Not applicable for an AI training set. For the development of the adhesive material, the "ground truth" would have been established through iterative laboratory testing and material science principles, aiming to meet desired performance characteristics and ultimately comply with ISO 4049:2000. These details are not part of the 510(k) summary.

Summary

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K072978

CONFIDENTIAL

XI. 510(k) Summary

JAN 1 7 2008

Submitter: Mr. Eugenio Miceli, QA Manager, Micerium SpA, Via Marconi, 83, 16030 Avegno (GE), Italy. Phone: 39 0185 7885 880.

I. Classification Name and Number: Bracket adhesive resin and tooth conditioner (DYH 872.3750)
Common/Usual Name: Adhesive for luting ceramic and metal orthodontic brackets. II.
III. Proprietary Name: Tender Ortho Bond - Ena Bond - Ena Etch
IV. Registration No .: Foreign, in process
V. "ISO 4049:2000 Dentistry - Polymer - Based Filling, Restorative and Luting materials".
VI. Premarket Notification truthful and accurate statement
VII. Description of the Device: Adhesive system, light curable both with halogen and LED Light, for brackets cementation. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally.
VIII. Labels and Labeling: Labels of the Tender Ortho Bond, Ena Bond and Ena Etch and instructions for use are provided.
IX. Substantial Equivalence: The Tender Ortho Bond system is substantially equivalent to other composite systems currently on the market used for direct and indirect restorations by dentist and dental technicians. A list of these is provided.

Tender Ortho Bond

The material is the bonding agent for brackets to the teeth.

The composition of Tender Ortho Bond the equivalent products are monomer resins (methacrylates) and starting agents to initiate the polymerisation.

Ena Bond tooth conditioner

The material is applied on the tooth surface after etching and is the bonding agent between the tooth and the composite material (Tender Ortho Bond).

The composition of the products are volatile solvents, matrix oligomers and bonding agents. Most of the equivalent products are very similar. Only the kind of solvent is different in some products.

Ena Bond is used after etching the tooth. Ena Etch is an etching gel 37% phosphoric

File; Tender Ortho Bond_510K.doc

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CONFIDENTIAL

acid similar to all the other existing etching gel available in the market for the etching of tooth.

Ena Bond SE tooth conditioner

Ena Bond SE is a two-component system (primer+bond) without fluoride, Transbond Plus SE is a one component system with fluoride.

IX.1 Risk to Health
Potential adverse affects and complications common to composite materials include:
1. Allergy to one of the ingredients
1. No / incomplete hold to the hard teeth substance
1. Leakage creation / danger of secondary caries
1. Irritant for eye and skin

cytotoxicity tests appears in appendix III

X Indications for Use. Adhesive for luting ceramic and metal orthodontic brackets.

(End of Summary)

We have made every effort to provide the data required for the Center for Devices and Radiological Health (CDRH) to make a substantial equivalence determination on the Tender Ortho Bond – Ena Bond.

The "ISO 4049:2000 Dentistry - Polymer - Based Filling, Restorative and Luting materials" issued September 13th, 2000 and more general documents on preparation of a 510(k) were followed. Your prompt consideration of this premarket notification -510(k) submission will be sincerely appreciated.

If we can provide further clarification or information, please call me or Ms Carla Tazzer (Quality Control) at +39 0185 7887 870 or send a fax at +39 0185 78 87 970 or e-mail to quality@micerium.it

Sincerely yours.

Eugenio Miceli A Manager.

MICERIUM S.p.A.
Via G. Marconi, 83 - 16030 AVEGNO (

Via G. Marconi, 83 - 16030 AVEGNO (GE)
Partita IVA 01199870104
Tel. 0185-7887870 Fax 0185-7887970

File: Tender Ortho Bond_510K.doc

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

JAN 17 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Eugenio Miceli Quality Assurance Manager MICERIUM S.p.A. Via Marconi, 83 Avegno, Genoa, ITALY 16030

Re: K072978

Trade/Device Name: Tender Ortho Bond - Ena Bond - Ena Etch Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: December 14, 2007 Received: December 31, 2007

Dear Dr. Miceli:

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.

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.

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Page 2- Dr. Miceli

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); 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.

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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Supite H. Michie Ows.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K072978

Device Name: Tender Ortho Bond – Ena Bond – Ena Etch

Indications for Use:

Adhesive for luting ceramic and metal orthodontic brackets

Prescription Use × (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runny

5072978

Page 1 of _ -

Regulation Number and Section

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.