# K993784: Unigraft

- Pathway: 510(k) (Traditional)
- Applicant: Unicare Biomedical
- Decided: Jan 27, 2000 after 80 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) PerioGlas®: named in the summary without a submission number
- (no number) BioGran®: named in the summary without a submission number
- (no number) OsteoGraf: named in the summary without a submission number

## Indications for use
For the repair of periodontal infrabony defects, extraction site and augmentation of the alveolar ridge

Source page: https://510kreport.com/device/K993784
Methodology: https://510kreport.com/methodology