[Federal Register Volume 78, Number 92 (Monday, May 13, 2013)]
[Notices]
[Pages 27971-27972]
From the Federal Register Online via the Government Publishing 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, [email protected],
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 [email protected] 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]
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