# K964342: Cytoplast GBR

- Pathway: 510(k) (Traditional)
- Applicant: Osteogenics Co.
- Decided: Mar 11, 1997 after 131 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: 1 generation back to K922627 (1994). 3 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922627: Gore-Tex Regenerative Material, W. L. Gore & Associates, Inc. (1994) Summary page 1.
- K935137: Tefgen-FD, American Custom Medical, Inc. (1994) Summary page 1.
- K950306: Imtec Biobarrier, Imtec Corp. (1996) Summary page 1.

## Most influential descendants
- K972278: Cytoplast Regentex Titanium 250 (1997), 7 descendants of its own
- K143327: Neoss Ti Reinforced Membrane (2015), 2 descendants of its own
- K012144: Cytoflex (2001), 2 descendants of its own
- K201187: Cytoplast Titanium-Reinforced PTFE Membranes (2021), 1 descendant of its own
- K160493: Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm (2016), 1 descendant of its own

## Indications for use
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.

Source page: https://510kreport.com/device/K964342
Methodology: https://510kreport.com/methodology