# K121114: Tigran Peribrush

- Pathway: 510(k) (Traditional)
- Applicant: Tigran Technologies AB
- Decided: Sep 17, 2012 after 158 days
- Product code: ELB (Scaler, Rotary)
- Device class: 2
- Regulation: 21 CFR 872.4840
- 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 K900709 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111724: Straumann Tibrush, Straumann USA (2011) Summary page 2.

## Indications for use
Tigran TM PeriBrush TM is a debridement instrument for titanium dental implants subjected to peri-implantitis. It is indicated for the open debridement of titanium Implant surfaces in bone defects caused by peri-implantitis.

Source page: https://510kreport.com/device/K121114
Methodology: https://510kreport.com/methodology