# K902078: Add'l Indication for Octyldent 2-Octyl Cranoacry.

- Pathway: 510(k) (Traditional)
- Applicant: Crx Medical, Inc.
- Decided: Aug 3, 1990 after 87 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K991923: Soothe-N-Seal Canker Sore Relief (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K902078
Methodology: https://510kreport.com/methodology