# K050984: Bioplant

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Dental Materials Center
- Decided: Aug 11, 2005 after 114 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Osteon Bone Grafting Material: named in the summary without a submission number
- (no number) Biomet, Inc., HIT-MW: named in the summary without a submission number

## Indications for use
Bioplant is a synthetically derived, spherical material which is intended to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region in the below indications: 1) To maintain and restore the bony alveolar ridge after extraction of tooth-roots, i.e., Ridge preservation/Socket grafting; 2) To restore infra-bony defects caused by destructive periodontal disease, i.e., 2-3 wall defects/Class I, II and III furcations; 3) To augment bony defects, i.e., apicoectomies, cystic formation or tumor removal; 4) Ridge augmentation to restore the height and/or width of severely atrophied alveolar ridges; 5) Augmentations in the maxillary sinus; 6) Bone voids associated with implant placement.

Source page: https://510kreport.com/device/K050984
Methodology: https://510kreport.com/methodology