# K972240: Imtec Biobarrier Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Imtec Corp.
- Decided: Aug 26, 1997 after 71 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
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 no predicate by number.

## 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.

Source page: https://510kreport.com/device/K972240
Methodology: https://510kreport.com/methodology