# K132325: Guidor Bioresorbable Matrix Barrier

- Pathway: 510(k) (Abbreviated)
- Applicant: Sunstar Americas, Inc.
- Decided: Oct 29, 2013 after 95 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: 4 generations back to K924408 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912724: Guidor (TM), Procordia Oratech AB (1993) Summary page 1.
- K051267: Gore Resolut Regenerative Material, Gore Resolut XT Regenerative Membrane, Gore Osseoquest Regenerative Membrane, W. L. Gore & Associates, Inc. (2005) Summary page 3.
- K033074: Inion GTR Biodegradable Membrane System, Inion, Ltd. (2004) Summary page 1.
- K050446: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2005) Summary page 1.
- K993610: Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250, Osteogenics Biomedical, Inc. (2000) Summary page 1.
- K053260: Ossix -Plus, Colbar Lifescience, Ltd. (2006) Summary page 1.

## Indications for use
GBR Configurations To aid in bone regeneration and augmentation in oral surgery for: - Extraction socket site preservation - Immediate implant placement at time of extraction or delayed placement when additional bone regeneration is desired, - Ridge augmentation - Sinus elevation - Stable barrier for the containment of bone grafting materials GTR Configurations To aid in the regeneration and integration of periodontal tissue components. For use as an adjunct in periodontal surgical treatment to supplement the reparative process following scaling and root planing for: - Class II furcations - intrabony defects - recession type defects

Source page: https://510kreport.com/device/K132325
Methodology: https://510kreport.com/methodology