Requires dentists and manufacturers to disclose the place of manufacture of a dental device, appliance, or material to the patient

Title of bill

An act to amend the public health law and the education law, in relation to the place of manufacture of dental prosthetics

Purpose or general idea of bill

To provide consumers information as to where their prosthetic dental devices, restorative appliances, and/or dental materials are manufactured prior to use.

Summary of specific provisions

Article 4-B of the Public Health Law, as added by Chapter 514 of the Laws of 2004, is amended by adding a new § 471 to require dentists and manufacturers to disclose the place of manufacture of a dental device, appliance, or material to the patient prior to these dental materials being placed in the patient's mouth. Any dental lab or manufacturer of dental devices and appliance who fails to provide this disclosure will be guilty of a violation punishable by a fine of up to one thousand dollars.

Section 6509 of the Education Law is amended by adding a new subdivision 13 to discipline dentist who fail to provide the disclosure information required pursuant to § 471 of the Public Health Law.

Justification

There is a growing concern among dentists, dental laboratories, and consumers that many foreign-manufactured dental prosthetics may contain harmful traces of lead. A recent report from the Midwest made national news attention when a woman became sick due to her led-tainted dental work which was outsourced to China. The National Association of Dental Labs and the American Dental Association estimate that 15-20% of all restorative work is outsourced. This bill will provide consumer protection measures to patients who undergo dental work which require dental prosthetics.

The US Food and Drug Administration (FDA) regulates the raw materials used to make dental prosthetics such as dental crowns and bridges. This federal entity is the regulatory authority for the registration of foreign labs that import dental products into the U.S. However, the National Association of Dental Laboratories argues that the FDA is inspecting less than 1% of the restorations that are coming in from foreign dental labs. The concern is that the raw materials used abroad to manufacture dental prosthetics may not meet U.S. standards.

Noting the issues surrounding the questionable safety of material alloys in the foreign made dental prosthetics, patients have the right to know the place of origin of the dental devices in their mouth. Furthermore, dentists have the light to receive notification of the place of origin of the dental devices before the dentists order the materials. Some domestic dental labs outsource their orders to foreign companies and the dentist who places the order never is aware of this outsourcing.

Dentists should be notified in advance when a domestic dental lab is going to outsource some or all of prescribed work.

Legislative history

2008: S.8296 Rules Cmte.

Fiscal implications

None.

Effective date

This act shall take effect on the ninetieth day after it shall have become a law.