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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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