Friday, May 24, 2013 9:03:41 AM
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM352560.pdf
In other words, even if the dental study meets the FDA requirments it might only be useful in obtaining clearance for that specific procedure and indication, not for general clearance. While any approval is good for BIEL, that's a very limited market.
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