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BioWorld - Tuesday, December 9, 2025
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Home » Australia’s Orthocell submits 510(k) for Celgro regenerative collagen medical device
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Australia’s Orthocell submits 510(k) for Celgro regenerative collagen medical device

May 22, 2020
By Tamra Sami
PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. has submitted a 510(k) application to the U.S. FDA for its Celgro collagen medical device for dental guided bone and soft tissue regeneration applications. The submission follows positive results from an FDA-guided bone regeneration study, which is a key component toward the goal of gaining U.S. marketing approval.
BioWorld MedTech Regulatory Orthopedics Australia 510(k) FDA

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