In Brief: Xytronyx
This article was originally published in The Gray Sheet
Xytronyx: Receives "approvable" letter from FDA for its PTM periodontal tissue monitor device. Final approval of the "chair-side" test for periodontitis remains contingent upon "certain manufacturing requirements and labeling issues," San Diego-based Xytronyx says. In September 1996, the firm submitted a revised premarket approval application for the device following an initial rejection by FDA in 1991 due to inadequate data ("The Gray Sheet" Nov. 18, 1991, In Brief). Formerly called the PerioGard, the device is sold in Europe by Hawe-Neos Dental. Xytronyx has signed a letter of intent with Steri-Oss for distribution of PTM in North America...
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