# K990363: Biomesh Biodegradable GTR Barrier

- Pathway: 510(k) (Traditional)
- Applicant: Samyang Corp.
- Decided: Apr 9, 1999 after 63 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 K932866 (1995). 3 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K932866: Resolut Regenerative Material, W. L. Gore & Associates, Inc. (1995) Summary page 1.
- K962624: Resolut Regenerative Material, W. L. Gore & Associates, Inc. (1996) Summary page 1.
- K973594: Gore Resolut XT Regenerative Material, W. L. Gore & Associates, Inc. (1997) Summary page 1.

## Most influential descendants
- K090083: Cytoflex Resorb, Model C03-0010 Through C03-090 (2009), 1 descendant of its own
- K253317: Cytrans™ Elashield (2026), 0 descendants of its own

## Indications for use
BioMesh® Biodegradable GTR Barrier is indicated for use in the treatment of the following specific conditions: Two or three wall vertical defects. Class Il furcations. Circumferrential defects. Recession type defects. Dehisence defects associated with dental implants

Source page: https://510kreport.com/device/K990363
Methodology: https://510kreport.com/methodology