General Criteria for Acceptance

A. Established or Generic Names: The selection and use of established or generic names must conform to the requirements of the Federal Food, Drug and Cosmetic Act.

B. Trade Names: Proprietary names will be acceptable to the Council provided the names meet certain professional standards.

Misleading Names: Names which are misleading or which suggest diseases or symptoms will not be acceptable. This provision may not apply to certain biological products such as serums or vaccines.

Unacceptable product names (as determined by, but not limited to, the above criteria) must be revised before Acceptance.

A. Product Information: A company is required to provide a quantitative statement of composition, including excipients, to the Council. For therapeutic agents, adequate information on the properties of all ingredients must also be provided. For materials, instruments and equipment, a description of the materials used in the construction and the method of operation must be provided. Any change in the composition, nature or function of an Accepted product must be submitted to the Council for review and approval before a modified product is marketed. A modified product is prohibited from using the ADA Seal unless and until it is approved by the Council.

B. Manufacturing Standards: The company must provide evidence that manufacturing and laboratory control facilities are under the supervision of qualified personnel, are adequate to assure purity and uniformity of products, and are in compliance with Good Manufacturing Practices. The company must agree to permit representatives of the Council to visit laboratories and factories upon request. For products whose guidelines include an official American National Standard Institute/American Dental Association Specification (ANSI/ADA Specification), the manufacturer is required to conduct testing on a regular basis to determine continued compliance with the specification. Upon request of Council, the company must make these test records available to the Council. In addition the manufacturer must make available to the Council on request test records and data for any batch of an Accepted product.

C. Complying with Guidelines and/or Specifications:

i. The company must provide evidence that a product demonstrates compliance with its relevant guideline and/or specification.

ii. The Council at any time and without notice to the company, may authorize the testing of such products.

iii. For Products which fall under the scope of official ANSI/ADA Specifications the following information must be submitted: (1) the serial or lot number; (2) the physical properties as obtained by standard test methods; and (3) data covering every provision of the official specification. Responsibility for guaranteeing that product complies with an official specification lies solely with the manufacturer and not with the American Dental Association.

iv. Test samples will be procured at the expense of the manufacturer as indicated in Section III. In the event that an Accepted product fails to comply with the appropriate specification, the ADA Seal of Acceptance will be withdrawn from the product, the license agreement will terminate immediately, and all rights of the company to use the ADA Seal will cease. All products that do not comply with the specification must be removed from the market. If the ADA Seal of Acceptance is withdrawn from a product, the product may be resubmitted at any time, provided adequate evidence of safety and effectiveness is submitted for Council review.

A. Submission of Evidence: Evidence must be submitted pertaining to: actions, safety and efficacy; and where applicable, mechanical and physical properties. Information on acceptable standard test methods for physical properties may be obtained from the Council on Scientific Affairs. In general, the data required on physical tests will include: methods, results, names of the observers, and dates of testing.

B. Nature of Evidence: The company must provide objective data from clinical and laboratory studies demonstrating safety and effectiveness. Evaluation of a product may also be based on similarity to a previously Accepted product. Products that fall under the scope of an official ANSI/ADA Specification will be tested for compliance with the specification by the ADA laboratory. Test samples, unless otherwise indicated in the appropriate specification, will be procured on the open market at the expense of the manufacturer.

C. Supplemental Evidence: All proprietary studies for the product as well as a list of all other studies conducted using the final product must be submitted. Additionally, the ADA may, through use of its own laboratory facilities or use of other facilities, conduct any additional evaluation deemed necessary by the Council.

D. Post Marketing Surveillance: Any new information regarding safety and efficacy must be submitted as it becomes available. This evidence may be in the form of new clinical studies, reports of adverse reactions or follow-up investigations of previously submitted clinical studies.

E. Renewal of Acceptance: The company may be required to submit evidence demonstrating continued acceptable clinical performance of the product. This evidence may be in the form of new clinical and/or laboratory studies, reports of adverse reactions or follow-up investigations of previously submitted clinical studies.

F. Disclosure: The company must disclose any past, present or anticipated financial arrangements between the investigators and the company, its affiliates or subsidiaries, including, but not limited to, consulting agreements, speakers' fees, grants or contracts to conduct research, or membership on the company's advisory committees including remuneration policies, or in the product that is the subject of the investigation. If the Council determines that the financial interests raise a question about the integrity of the data, the Council may take any action it deems necessary to ensure the reliability of the data, including but not limited to:

• requesting that the company submit further analyses of the data;

• requesting that the company conduct additional independent studies; and

• rejecting the data as a basis for council action.

A product must conform to all applicable laws and governmental regulations.

The American Dental Association is concerned about the environment and about the negative impact that the widespread use of non-biodegradable materials for the manufacture and packaging of disposable products can have on the environment. Therefore, the ADA encourages all dental manufacturers, especially those with Accepted products, to use, whenever possible, materials that are biodegradable and/or recyclable.

A. Name: The established or generic name of a product must be displayed in a prominent manner in all material directed to the dental profession.

B. Claims: Claims of significance to dentistry for a product must be clear and accurate.

C. Packaging/Labeling: All packaging/labeling must be submitted to the Council for review and approval prior to use.

D. Advertising: Advertising must conform to the ADA's advertising standards and certification mark usage guidelines. The ADA's name and the ADA Seal and Seal Statement may appear in advertising and promotional materials, to include point-of-purchase advertising if it is presented in good taste and professional dignity and is only part of the commercial message. The Seal statement sets forth the basis for acceptance by the Council and must be used whenever the Seal is used, unless otherwise authorized by the Council.

E. Disparagement of Other Products: Advertising of an Accepted product must not result in the disparagement of other products.

F. Implied Acceptance: An Accepted product must not be advertised or displayed with unaccepted products in a manner that implies Acceptance of the unaccepted product. This provision does not apply to conventional price lists or catalogs.

G. Responsibility: The responsibility of providing substantiation of claims for safety and efficacy or claims of compliance with an official standard must reside with the manufacturer and not with the American Dental Association. A company’s labeling and advertising statements concerning those attributes evaluated by the ADA and appearing in the ADA statement accompanying the ADA Seal certification mark must be consistent with the supporting evidence provided to the ADA by the company.

A. Any reference to the Council in labeling, package inserts, advertising and other promotional material for an Accepted product is permitted solely to indicate to the profession or public that the claims for product effectiveness in treating or preventing oral disease are valid.

B. The Seal of Acceptance may only be used after notification of Acceptance in writing by the Council and execution of the ADA's standard ADA Seal license agreement. The ADA Seal must not appear in conjunction with the seal or certification mark of any other investigative group unless approval for such display has been obtained from the Council. The ADA Seal is to be used without comment on its significance unless the Council has previously approved such comment. The Seal must be legible and must not be used in any manner that detracts from its dignity.

C. The same principles established for the use of the ADA Seal must apply to the Seal Statement.

The ADA reserves the right to make changes to the ADA Seal of Acceptance Program at any time at its sole discretion. Such changes may include, by way of example only and without limitation, changes to the guidelines or specifications, testing criteria, license agreement or advertising standards. Note that in some instances, changes to the Program may result in the permanent withdrawal of the ADA Seal from a product or product category. If the foregoing circumstance occurs, ADA will determine the date by which the license agreement will terminate and will notify affected companies accordingly. All rights of a company to use the ADA Seal will cease upon termination of the license agreement.

The Council may on occasion find it necessary to permanently withdraw the ADA Seal of Acceptance from a product or product category. Such decisions may be made at any time at the sole discretion of the Council.

Any violation of the ADA Seal license agreement is grounds for Council's withdrawal of the ADA Seal of Acceptance from the Product.

It is the policy of the American Dental Association to treat the material submitted for Council review as confidential. Any confidential information submitted by a company should be marked as "confidential," "proprietary" or with a similar legend indicating its confidential nature.

Although ADA utilizes outside consultants in its review of products, ADA Seal Program consultants are required to sign the ADA's Code of Conduct. The Code of Conduct requires the consultants to refrain from disclosing confidential product submission materials to anyone outside the ADA. Except as required to evaluate a product submission or otherwise implement the ADA's Seal of Acceptance Program or as may be required by law, ADA refrains from voluntarily disclosing properly marked product submission materials to any third party without the prior consent of the manufacturer. ADA also takes commercially reasonable steps to ensure that such materials are not disclosed or distributed by its employees, consultants or other agents. However, ADA will not be liable for any damages resulting from the acts or omissions of ADA consultants, including but not limited to their failure to abide by the Code of Conduct.

ADA does not treat as confidential any information that (i) is or becomes a part of the public domain through no act or omission of ADA; (ii) was in ADA's lawful possession prior to the disclosure; (iii) is lawfully disclosed to ADA by a third party without restriction on disclosure; or (iv) is independently developed by ADA without use of or reference to the company's Confidential Information.