# K063634: RTR Syringe

- Pathway: 510(k) (Abbreviated)
- Applicant: Septodont
- Decided: May 11, 2007 after 156 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K093871: Periophil B-TCP (2010), 0 descendants of its own

## Indications for use
RTR® SYRINGE is designed for the replacement of bone losses, after being impregnated with the patient’s blood or with a physiological solution for craniofacial indications in the dental practice such as filling tooth sockets.

Source page: https://510kreport.com/device/K063634
Methodology: https://510kreport.com/methodology