# K012047: 3I Calcium Sulfate Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Sep 19, 2001 after 82 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) CAPSET® Calcium Sulfate Bone Graft Plaster: named in the summary without a submission number

## Indications for use
3i®'s Calcium Sulfate Bone Cement is used over a filled defect providing a stable barrier to graft material migration and is also indicated for use as a binder of bone graft particles. For use in dental applications only.

Source page: https://510kreport.com/device/K012047
Methodology: https://510kreport.com/methodology