# K032708: Plastalgin and Plastalgin Ortho

- Pathway: 510(k) (Traditional)
- Applicant: Septodont
- Decided: Nov 20, 2003 after 79 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- 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
Use Plastalgin for all routine impressions (e.g., denture dentition construction, orthodontics, study models, or other such routine impressions). Use Plastalgin Ortho when a faster setting time is needed (e.g., procedure with children, patients with nauseous reflex during impression procedures).

Source page: https://510kreport.com/device/K032708
Methodology: https://510kreport.com/methodology