# K223912: InterCollagen® Guide

- Pathway: 510(k) (Traditional)
- Applicant: Sigmagraft, Inc.
- Decided: Aug 17, 2023 after 231 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: 7 generations back to K924408 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173562: Straumann Jason Membrane, Institut Straumann AG (2018) Summary page 4.

## Indications for use
InterCollagen® Guide alone or in combination with suitable augmentation materials (like autogenous bone, allogeneic, xenogeneic or alloplastic bone replacement materials) is indicated for immediate or delayed guided tissue and bone regeneration. • in the context of a treatment of fenestration defects • in case of dehiscence defects • after apicoectomy and resection of retained teeth • in extraction sockets after tooth extractions • in case of immediate or delayed augmentation around implants in extraction sockets

Source page: https://510kreport.com/device/K223912
Methodology: https://510kreport.com/methodology