# K980159: Octyldent (2-Octyl Cyanoacrylate), 02A01

- Pathway: 510(k) (Traditional)
- Applicant: Closure Medical Corp.
- Decided: Apr 9, 1998 after 83 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.
2 later devices descend from it; 2 cite 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K013446: Glusite, Model GLU002 (2001), 0 descendants of its own
- K991923: Soothe-N-Seal Canker Sore Relief (1999), 0 descendants of its own

## Indications for use
Octyldent® is intended for use as an adhesive for the temporary fixing of periodontal polymer or fibers in periodontal pockets.

Source page: https://510kreport.com/device/K980159
Methodology: https://510kreport.com/methodology