The Dental Products Panel (the Panel) met on Tuesday, October 11 and Wednesday, October 12, 2005, in Gaithersburg, MD, to make a recommendation to the Food and Drug Administration (FDA) on the classification of seven pre-amendments, unclassified dental devices and on the over-the-counter (OTC) use of dental mouthguards.
The seven devices and the Panel's recommendations are as follows.
|Device||Recommended Class||Specific Recommendation|
|Artificial Saliva||Class II (Special Controls)||Guidance Document|
|Retraction Cord||Class I (Exempt) without drugs
Class II (Special Controls) with drugs
|Oral Wound Dressing||Class II (Special Controls)||Guidance Document|
|Dental Electrical Anesthesia||Class II (Special Controls)||Guidance Document and Performance Standards|
|Root Canal Cleanser||Class II (Special Controls)||Guidance Document|
|Root Apex Locator||Class II (Special Controls)||Guidance Document|
|Dental Mouthguard||Class II (Special Controls)||Guidance Document|
Of particular note, the Panel felt uneasy about the effectiveness of dental electrical anesthesia and believed performance standards are necessary for the device. Also, during the open public session stakeholders presented evidence that dental mouthguards were OTC as well as prescription prior to the passing of the medical device amendments of 1976.
Regarding the OTC use of dental mouthguards, the Panel considered FDA and industry’s presentations and had the following recommendations:
- Tooth grinding and bruxism are appropriate indications for OTC use. Other indications may not be.
- Adequate labeling can be written such that a lay person may determine their need for the device.
- OTC use is not appropriate for all designs of mouthguards.
- The labeling suggestions, particularly with regards to the need to see a professional if pain is involved, as presented by the industry speaker were supported.
- A clinical study is not needed to support an OTC indication for tooth grinding and bruxism indications.
Contact: Michael E. Adjodha, Executive Secretary, at 301-827-5283, ext. 123, or via email at: email@example.com.
A complete transcript will be available at:
Transcripts may be purchased from:
Neal R. Gross & Company
1323 Rhode Island Avenue, NW
Washington, DC 20005
The Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
301-827-6500 (voice) or 301-443-1726 (FAX)