# K201051: Straumann BoneCeramic

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Sep 24, 2020 after 156 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
Longest line of descent: 4 generations back to K960978 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040646: Straumann Granules, The Straumann Co. (2004) Summary page 5.

## Indications for use
Straumann® BoneCeramic is indicated for filling and/or augmenting the following intraoral/maxillofacial osseous defects:  Intrabony periodontal osseous and furcation defects  Augmentation of bony defects of the alveolar ridge  Filling tooth extraction sites  Sinus elevation grafting

Source page: https://510kreport.com/device/K201051
Methodology: https://510kreport.com/methodology