# K150079: Regenomer® Syringe, Regenomer® Plug, Regenomer® Block

- Pathway: 510(k) (Abbreviated)
- Applicant: Nibec Co., Ltd.
- Decided: Dec 10, 2015 after 329 days
- Product code: NPM (Bone Grafting Material, Animal Source)
- 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 K974399 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040783: Foundation, Terumo Corp. (2004) Summary page 4.

## Indications for use
The Regenomer® is in general recommended for the filling of extraction sockets and periodontal defect. The indication for use depending on the device format is further classified as described in following table. Format: Syringe — Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR); filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). Format: Plug — Filling of extraction sockets; augmentation or reconstructive treatment of the alveolar ridge; elevation of maxillary sinus floor. Format: Block — Augmentation or reconstructive treatment of the alveolar ridge; elevation of maxillary sinus floor.

Source page: https://510kreport.com/device/K150079
Methodology: https://510kreport.com/methodology