# P830035: GK-101E Caries Removal Agent/System

- Pathway: PMA
- Applicant: Indevus Pharmaceuticals, Inc.
- Decided: Jul 6, 1984 after 371 days
- Product code: LMW (Solution, Removal, Carries)
- Device class: 3
- 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. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P830035
Methodology: https://510kreport.com/methodology