[Federal Register Volume 78, Number 92 (Monday, May 13, 2013)]
[Notices]
[Pages 27971-27972]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11286]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0677]


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's regulatory issues.
    Date and Time: The meeting will be held on July 18th, 2013, from 8 
a.m. to 2:30 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B and 
C, 620 Perry Pkwy., Gaithersburg, MD,

[[Page 27972]]

20877. The hotel phone number is 301-977-8900.
    Contact Person: Sara J. Anderson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg 66, Rm. 1611, Silver Spring, MD, Sara.Anderson@fda.hhs.gov, 
301-796-7047, or FDA Advisory Committee Information Line, 1-800-741-
8138 (301-443-0572 in the Washington, DC area). A notice in the Federal 
Register about last minute modifications that impact a previously 
announced advisory committee meeting cannot always be published quickly 
enough to provide timely notice. Therefore, you should always check the 
Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm 
and scroll down to the appropriate advisory committee meeting link, or 
call the advisory committee information line to learn about possible 
modifications before coming to the meeting.
    Agenda: On July 18, 2013, the committee will discuss and make 
recommendations on the proposed regulatory classification for dental 
devices known as Endosseous Dental Implants (Blade-form), one of the 
remaining preamendments Class III devices. The Class III blade-form 
endosseous dental implant is a device placed into the maxilla or 
mandible and composed of biocompatible material, such as commercially 
pure titanium, with sufficient strength to support a dental 
restoration, such as a crown, bridge, or denture, intended for the 
purpose of replacing tooth (or teeth) roots and extending a support 
post through the gingival tissue into the oral cavity to restore 
chewing function. The blade-form implant is generally a rectangular 
shape or rounded corner rectangle shape (in the mesio-distal plane) 
with a narrow tapered (narrow at the apical edge) edge (in the bucco-
lingual plane) similar in shape to a razor blade. Other blade designs, 
such as square, V-shaped, and triangles have also been used. The blade-
form implants are either one-piece or two-piece implants designed with 
one to three cylindrical abutment posts extending from the coronal 
aspect of the blade through the soft tissue and into the oral cavity.
    On January 4, 2013 (FDA-2012-N-0677), FDA issued a proposed order 
which, if made final, would reclassify the blade-form endosseous dental 
implant into class II (special controls). The committee's discussion 
will involve making recommendations regarding regulatory classification 
to either reaffirm Class III or reclassify these devices into Class II 
and comment on whether the proposed Special Controls are adequate to 
reasonably ensure the safety and effectiveness of blade-form endosseous 
dental implants. The regulatory history of blade-form endosseous dental 
implant has been discussed as part of the proposed order (FDA-2012-N-
0677).
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    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 on or before July 
9, 2013. On July 18, 2013, oral presentations will be scheduled between 
approximately 1 p.m. and 2 p.m. Those individuals interested in making 
formal oral presentations should notify the contact person 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 on or before June 28, 2013. Time allotted for each 
presentation may be limited. If the number of registrants requesting to 
speak is greater than can be reasonably accommodated during the 
scheduled open public hearing session, FDA may conduct a lottery to 
determine the speakers for the scheduled open public hearing session. 
The contact person will notify interested persons regarding their 
request to speak by July 1, 2013.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    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, at Annmarie.Williams@fda.hhs.gov or 301 
796-5966 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11286 Filed 5-10-13; 8:45 am]
BILLING CODE 4160-01-P