# K093871: Periophil B-TCP

- Pathway: 510(k) (Traditional)
- Applicant: Cytophil, Inc.
- Decided: Apr 22, 2010 after 126 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: 6 generations back to K990131 (1999). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063634: RTR Syringe, Septodont (2007) Summary page 2.
- K051885: MBCP, Biomatlante (2005) Summary page 2.
- K082917: Mastergraft Resorbable Ceramic Granules, Medtronic Sofamor Danek (2009) Summary page 2.

## Indications for use
Periophil β-TCP is indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Periophil β-TCP can be used with autogenous bone grafting materials. Typical uses include: periodontal/infrabony defects, ridge augmentation, extraction sites (implant preparation/placement), sinus lifts, and cystic cavities.

Source page: https://510kreport.com/device/K093871
Methodology: https://510kreport.com/methodology