# K811767: Coltene President Impression Materials

- Pathway: 510(k) (Traditional)
- Applicant: Coltene, Inc.
- Decided: Jul 15, 1981 after 23 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.
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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K220097: PRESIDENT The Original (2022), 1 descendant of its own
- K242360: Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K811767
Methodology: https://510kreport.com/methodology