[Federal Register: September 15, 2005 (Volume 70, Number 178)]
[Page 54559-54560]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Dental Products Panel of the Medical Devices Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Dental Products Panel of the Medical Devices 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on October 11, 2005, from 
9:15 a.m. to 5:45 p.m., and on October 12, 2005, from 8 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Ballroom Salons 
A and B, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Michael E. Adjodha, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug

[[Page 54560]]

Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-
5283, ext. 123, e-mail: mea@cdrh.fda.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512518. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On October 11, 2005, the committee will hear a presentation 
on the FDA Critical Path Initiative and a presentation by the Office of 
Surveillance and Biometrics in the Center for Devices and Radiological 
Health outlining their responsibility for the review of postmarket 
study design. Subsequently, on October 11 and 12, 2005, the committee 
will discuss and make recommendations on the classification of the 
following unclassified dental devices:
     Root canal cleanser, product code KJJ, intended to cleanse 
a root canal after endodontic instrumentation;
     Retraction cord, product code MVL, intended for temporary 
retraction and hemostasis of the gingival margin;
     Root apex locator, product code LQY, intended to measure 
the length of the root canal;
     Dental mouthguards, product code MQC, intended to provide 
protection against bruxism, teeth clenching, and grinding;
     Artificial saliva, product code LFD, intended for the 
relief of chronic and temporary xerostomia;
     Oral wound dressing, product code MGQ, intended to provide 
pain relief from aphthous ulcers, canker sores, and minor oral lesions; 
     Electrical anesthesia, product code LWM, intended, through 
the application of electrical current, to provide analgesia or 
anesthesia during dental procedures.
    Also, on October 12, 2005, the committee will discuss and make 
recommendations regarding the over-the-counter (OTC) use of dental 
mouthguards.Background information for the topics, including the agenda 
and questions for the committee, will be available to the public 1 
business day before the meeting on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html.
 More information regarding product code 

classification can be accessed by visiting http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

by contact person. Material for the October 11 and 12 sessions will be 
posted on October 7, 2005.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by October 3, 
2005. On October 11, 2005 and October 12, 2005, oral presentations from 
the public will be scheduled for approximately 30 minutes at the 
beginning of committee deliberations and for approximately 30 minutes 
near the end of the deliberations. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before October 3, 2005, and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact AnnMarie Williams, 
Conference Management Staff, 301-594-1283, ext. 113, at least 7 days in 
advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 6, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-18363 Filed 9-14-05; 8:45 am]