Orthocell Limited announced that it has achieved FDA 510(k) clearance to market and supply its CelGro collagen medical device for dental bone and tissue regeneration procedures in the US. The FDA 510(k) clearance now allows Orthocell to supply Striate+ in the US dental market, estimated at USD 500 million per annum. Striate+ has been approved for supply in dental bone and tissue regeneration procedures such as dental bone defect repair, augmentation around dental implants in immediate and delayed extraction sockets and guided tissue regeneration procedures in intrabony periodontal defects. The 510(k) clearance follows the Company's application submitted to the FDA in May 2020. The FDA determined that, for the indications above, Orthocell's Striate+ is substantially equivalent to a predicate device and can therefore market Striate+ in the US. Striate+ has, based on surgeon feedback, distinct advantages over other similar products and may assist surgeons to deliver improved patient outcomes through superior handling characteristics, tissue integration qualities and improved bone healing.