# K220097: PRESIDENT The Original

- Pathway: 510(k) (Traditional)
- Applicant: Coltène/Whaledent AG
- Decided: Jan 13, 2022 after 1 day
- 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
Longest line of descent: 5 generations back to K943574 (1994). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811767: Coltene President Impression Materials, Coltene, Inc. (1981) Summary page 4.
- K152861: Aquasil Ultra + Smart Wetting Impression Material, Dentply International, Inc. (2016) Summary page 6.

## Most influential descendants
- K242360: Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator (2024), 0 descendants of its own

## Indications for use
PRESIDENT The Original Xtra light body / light body / regular body: * Correction material for the corrective impression technique * Injection material for the double mix technique * Injection material for the dual arch technique)) * Lining impression material PRESIDENT The Original heavy body: * Impression material for pick-up impression in the double mix technique * Tray material for corrective impression technique * Tray material for dual arch technique PRESIDENT The Original System 360: * Impression material for pick-up impression in the double mix technique * Tray material for corrective impression technique * Tray material for dual arch technique PRESIDENT The Original putty / putty soft / putty super soft / fast putty soft * Impression material for pick-up impression in the double mix technique * Tray material for corrective impression technique

Source page: https://510kreport.com/device/K220097
Methodology: https://510kreport.com/methodology