# K973539: Roeko Calcium Hydroxide Points

- Pathway: 510(k) (Traditional)
- Applicant: Roeko USA, Inc.
- Decided: Oct 30, 1997 after 42 days
- Product code: EJK (Liner, Cavity, Calcium Hydroxide)
- Device class: 2
- Regulation: 21 CFR 872.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TempCanal™: named in the summary without a submission number

## Most influential descendants
- K032662: Guttaflow (2003), 1 descendant of its own
- K190510: GuttaSil (2019), 0 descendants of its own

## Indications for use
For calcium hydroxide root canal therapy either prior to or after root canal preparation; for emergency root canal treatment; for treatment of root resorptions; and for early childhood trauma.

Source page: https://510kreport.com/device/K973539
Methodology: https://510kreport.com/methodology