|Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.|
|Trade Name||PERIOGARD PERIODONTAL TISSUE MONITOR|
|Generic Name||peridontal tissue monitor|
|Docket Number|| 98M-0036|
|Notice Date|| 01/27/1998|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the periogard periodontal tissue monitor (ptm). This device is indicated for use as a rapid, chair-side, visual test for the qualitative determination of aspartate aminotransferase (ast) in gingival crevicular fluid. The ptm kit detects elevated levels of ast assocaited with tissue necrosis. It is intended to be used as an objective, biochemical adjunct to traditional methods of monitoring patients to assist in the decision to apply treatment and in the evaluation of treatment effectiveness.