A Dental Products Panel (Panel) meeting was held on May 22, 2003 to consider a petition to reclassify beta-tricalcium phosphate from Class III to Class II. Beta-tricalcium phosphate is regulated as a Class III transitional device under 21 CFR 872.3930, “Tricalcium Phosphate Granules for Dental Bone Repair.” The meeting was chaired by Dr. E. Dianne Rekow. The petitioner argued that the device should be reclassified because it is inconsistent that the device is regulated as Class III only for dental indications, whereas it is regulated via Premarket Notifications for orthopedic and restorative indications. As a rebuttal, a current PMA holder of the device presented an argument during the Open Public Hearing that the device should remain as Class III because the device is difficult to make and use properly.
The Panel determined that the risks and appropriate mitigations of the device could be defined in a special controls guidance document and unanimously voted to move all tricalcium phosphate materials classified under 21 CFR 872.3930, Tricalcium Phosphate Granules for Dental Bone Repair, from Class III to Class II (Special Controls). The Panel further indicated that some consideration should be made regarding what pediatric indications would be appropriate and placed this reclassification as a “high priority” for the Agency.
Contact: Michael E. Adjodha, Executive Secretary,
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Under normal circumstances, panel summary minutes are available 60-90 days post meeting. Summaries are also available on the CDRH web site.