[UniverCité] Lumendo receives the FDA Clearance

[UniverCité] Lumendo receives the FDA Clearance

Lumendo is happy to announce a successful FDA Clearance of its dental filler material. They managed to get the FDA Clearance in 58 days instead of the expected 6 to 8 months. The clearance is linked to its endodontic root canal filler. The FDA regulates fillers as class II medical devices, which are subject to premarket notification via the 510(k) process. Bases on this clearance, Lumendo can legally market the filler for permanent root canal obturation in the US.

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