Please help us alert the FDA to the perils of Sargenti Paste by submitting a MedWatch report if you, or any patient that you treat, is injured by it. Medwatch reports can be made anonymously. The link to the Medwatch report is in upper right hand corner of this page.

1971 FDA meeting between Dr Angelo Sargenti and the FDA

1975 Hearings Before a Subcommittee on Government Operations, House of Representatives, 94th Congress

1992 AES Citizen's Petition to the FDA

1992 FDA Acknowledgment of Receipt of 1992 Citizen's Petition

1993 FDA Reply to 1992 Citizen's Petition

1993 FDA Dental Products Panel Meeting

1998 FDA Request to Advise on Status of 1992 Citizen's Petition

1998 AES Request to Grant 1992 Citizen Petition

2008 AES Withdrawal of 1992 Citizen's Petition

Read the FDA DRAFT GUIDANCE on The Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents as referred to in the Withdrawal of the Citizen's Petition (above link). A final version to the FDA guidance document is due out shortly. This version will define the requirements for devices that can follow the 510k process. Any device with a new chemical entity (NCE) which has not been previously approved by CDER (FDA Center for Drug Evaluation and Research) will not be approved for the simplified 510K process. Sargenti Paste was never approved by CDER. Even in some cases, where the abbreviated process is a possible approval path, the antimicrobial safety and effectivity data will still be required.

A clinical study requires patient knowledge and consent appears to not have been obtained for all of the thousands of cases submitted to the FDA. This issue was discussed in the transcript for the failed 1993 approval attempt. Were patient's rights under doctrines such as the Neuremberg act violated?

As always, we invite the AES and N2 Products to provide comment.. The information that we present on this site is the result of our research as a dental advocate organization.