# K974752: Imtec/Biobarrier Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Imtec Corp.
- Decided: Mar 3, 1998 after 74 days
- Product code: NPK (Barrier, Synthetic, Intraoral)
- 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 K960724 (1997). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960724: Bio-Gide Resorbable Bilayer Membrane, Geistlich-Pharma (1997) Summary page 1.

## Most influential descendants
- K012144: Cytoflex (2001), 2 descendants 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
- K222549: OpenTex (2023), 0 descendants of its own
- K113049: Socket Graft (2012), 0 descendants of its own

## Indications for use
IMTEC BioBarrier is a temporarily implantable material intended to be used as a space maintaining barrier over bone. It is intended for use in the oral cavity. The material is conformable to a variety of shapes as required for specific anatomical limitations. The IMTEC BioBarrier is additionally indicated for: - simultaneous use of GBR-membrane (BioBarrier) and implants: - augmentation around implants placed in immediate extraction sockets; - augmentation around implants placed in delayed extraction sockets; - localized ridge augmentation for later implantation. Because of its elasticity, the IMTEC BioBarrier should be used in combination with space-making bone graft materials, e.g., autogenous bone or bone substitutes.

Source page: https://510kreport.com/device/K974752
Methodology: https://510kreport.com/methodology