Food and Drug
Administration
Dental Products
Panel Meeting
November 9, 2006
Draft Questions
for Panel Consideration
1. Given the conditions studied, please discuss whether the
information provided by the sponsor provides a reasonable
assurance that the device is safe for all indications requested.
2. Please discuss the effectiveness results
obtained for sinus augmentation. In your discussion please
comment on:
a) The results of the primary and secondary
endpoints.
b) The results as compared to autogenous bone
grafting.
3. Given the conditions studied, does the information
provided by the sponsor provide a reasonable assurance that
the device is effective for sinus augmentation?
4. Support for the sponsor’s extraction
socket indication consists of a dosing study where the primary
objectives were to find the appropriate dose and to evaluate
bone growth in terms of height and width. Given the conditions
studied, does the information provided by the sponsor provide
a reasonable assurance that the device is effective2 for extraction
socket augmentation?
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