BioLok receives FDA clearance for time-release bone augmentation product

By Elaine Rigoli

Tampa, Fla., March 22 - BioLok International, Inc. has received 510(k) clearance from the Food and Drug Administration to market BoneGen-TR, a nano-composite, time-release calcium sulfate product used for bone regeneration, augmentation and as a soft tissue barrier in implantology, periodontology, endodontics and oral surgery.

A pure calcium sulfate product (BoneGen) was previously approved for marketing by BioLok and has been sold by the company for use in implant dentistry, according to a news release.

The limitations of traditional calcium sulfate led BioLok to develop BoneGen-TR, the release said.

Existing forms of calcium sulfate products may be resorbed too rapidly by the body, before full bone defect filling can be accomplished. The new BoneGen-TR product has an 18-week period over which full resorbtion occurs, compared to a four-week resorbtion period for previous products offered.

This allows the user to fill larger voids and get full bone regeneration, the release said.

BioLok is ready for limited distribution of BoneGen-TR in the United States for clinical evaluation and intends to have the product available for mass distribution this summer.

The broad bone augmentation market is estimated at $1 billion annually.

BioLok, based in Deerfield Beach, Fla., develops products for the dental implant and tissue regeneration markets.

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