# K051267: Gore Resolut Regenerative Material, Gore Resolut XT Regenerative Membrane, Gore Osseoquest Regenerative Membrane

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Jun 15, 2005 after 30 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: 2 generations back to K960724 (1997). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 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.
- K001598: Biobar, Implantable Biodegradable Collagen Membrane for Guided Bone Regeneration, Col-Bar, Ltd. (2000) Summary page 1.
- K011695: Collagen Dental Membrane, Collagen Matrix, Inc. (2001) Summary page 1.

## Most influential descendants
- K091120: Medpor Contain Implant (2010), 1 descendant of its own
- K132325: Guidor Bioresorbable Matrix Barrier (2013), 0 descendants of its own
- K102184: Medpor Contain Can Implant (2011), 0 descendants of its own

## Indications for use
it is intended for use during the process of guided bone regeneration as a bioabsorbable membrane for supporting: augmentation around immediately placed endosseous implants or existing endosseous implants (e.g., dehiscence and fenestration defects, extraction sockets); ridge augmentation for later implantation of endosseous implants; and sinus procedures (e.g., sinus window, sinus lift).

Source page: https://510kreport.com/device/K051267
Methodology: https://510kreport.com/methodology