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

[Federal Register Volume 62, Number 244 (Friday, December 19, 1997)]
[Notices]
[Page 66635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33096]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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 regulatory issues.
    Date and Time: The meeting will be held on January 12, 1998, 10:15 
a.m. to 5 p.m., and January 13, 1998, 8 a.m. to 5 p.m.
    Location: Corporate Bldg., conference room 020B, 9200 Corporate 
Blvd., Rockville, MD.
    Contact Person: Pamela D. Scott, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-5283, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 12518. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: On January 12, 1998, the committee will discuss and vote on 
a premarket approval application for a bone filling and augmentation 
device for periodontal use. On January 13, 1998, the committee will 
discuss and make recommendations to FDA regarding the reclassification 
of subgroups of endosseous dental implant devices. The following 
subgroups of endosseous implants will be included: Coated and uncoated 
root form implants, coated and uncoated blade-type implants, temporary 
implants, and implants with special enhanced retention features.
    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 December 29, 
1997. Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. and 11:30 a.m. on January 12, 1998, and 
between approximately 8:10 a.m. and 9:10 a.m. on January 13, 1998. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
January 5, 1998, 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 presentation.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 12, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-33096 Filed 12-18-97; 8:45 am]
BILLING CODE 4160-01-F