# K133507: Guidoss

- Pathway: 510(k) (Traditional)
- Applicant: Nibec Co., Ltd.
- Decided: Nov 5, 2014 after 356 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: 4 generations back to K924408 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050446: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2005) Summary page 4.
- K100695: Colladental Barrier, Collamatrix, Inc. (2013) Summary page 4.

## Indications for use
GuidOss® is recommended for: 1. Simultaneous use of membrane (GuidOss®) and implants : 2. Augmentation around implants placed in placed in immediate extract sockets; 3. Augmentation around implants placed in delayed extraction sockets; 4. Localized ridge augmentation for later implantation; 5. Alveolar ridge reconstruction for prosthetic treatment 6. Filling of bone defects after root resection, cystectomy, removal of retained teeth. 7. Guided bone regeneration in dehiscence defects; and 8. Guided tissue regeneration procedures in periodontal defects.

Source page: https://510kreport.com/device/K133507
Methodology: https://510kreport.com/methodology