# K231305: Endoform Dental Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Aroa Biosurgery, Ltd.
- Decided: Jan 23, 2024 after 263 days
- Product code: NPL (Barrier, Animal Source, 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: 2 generations back to K010952 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082058: Dynamatrix, Cook Biotech, Inc. (2008) Summary page 5.

## Indications for use
Endoform Dental Membrane is specifically intended for use in extraction sockets and soft tissue grafting. The device contains and prevents migration of guided bone regeneration graft material and prevents loss of alveolar height and ridge following tooth extraction. The device is provided sterile and intended for one-time use.

Source page: https://510kreport.com/device/K231305
Methodology: https://510kreport.com/methodology