# K980783: Simplex Saliva Absorber/Collector, Model Ssa-5

- Pathway: 510(k) (Traditional)
- Applicant: Irt Management Corp.
- Decided: Apr 21, 1998 after 50 days
- Product code: KHR (Absorber, Saliva, Paper)
- Device class: 1
- Regulation: 21 CFR 872.6050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
For the absorption/Collection and removal of excessive saliva during dental procedures. For the absorption/Collection and removal of saliva when excessive saliva is seen collecting in the mouth. For the absorption/Collection and removal of saliva in General Pediatric Use. For the absorption/Collection and removal of saliva whenever a potential choking hazard exists with commonly used saliva absorbers. For the absorption and removal of saliva when typical “suction” type devices are not appropriate or effective. For the collection of saliva when other absorber devices or suction devices are not appropriate or tolerated easily by the patient.

Source page: https://510kreport.com/device/K980783
Methodology: https://510kreport.com/methodology