Bone grafting material (FDA dental device category)

The regulation identifies bone grafting material as “a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.” It is Class II — subject to special controls and cleared through a 510(k) premarket notification — for materials that do not contain a drug that is a therapeutic biologic, and Class III, requiring premarket approval, for materials that do.

FDA’s device classification database assigns four product codes under the regulation, as retrieved from openFDA on September 11, 2026:

Code	Device name	Class
LYC	Bone grafting material, synthetic	II
NPM	Bone grafting material, animal source	II
NUN	Bone grafting material, human source	II
NPZ	Bone grafting material, dental, with biologic component	III

The code is assigned by the origin of the graft material, not by its handling form: a granule, a putty, a block and a collagen plug of the same origin sit under the same code. The presence of a carrier does not by itself change the code, though a carrier of animal origin in an otherwise synthetic product is a question for the review. In August 2025 FDA issued final guidance on the animal studies expected in 510(k) submissions for this category.

On this site

ALGINAGRAFT™ has not been submitted to FDA under any code. Which code a future configuration would fall under depends on the particulate graft selected and is determined by FDA; see development status.