510(k) · Cleared
ClearedPRESIDENT The Original
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coltène/Whaledent AG · ELW Material, Impression
Cleared on Jan 13, 2022 as substantially equivalent to K811767 (Coltene, Inc., 1981) and 1 other predicate after a 1-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Jan 13, 2022
- Review
- 1 day
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K943574 (1994). 9 ancestors in all, the oldest K811767 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 4 generations backK973782 Aquasil XLV Smart Wetting Impression MaterialDentsply Intl. · 1997
- 3 generations backK021410 Aquasil Ultra XLV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 2 generations backK113406 Aquasil Ultra Smart Wetting Impression MaterialDentsply International, Inc. · 2012
- 1 generation backK152861 Aquasil Ultra + Smart Wetting Impression MaterialDentply International, Inc. · 2016
- This deviceK220097 PRESIDENT The OriginalColtène/Whaledent AG · 2022
- Descendant · cites it directly · 0 of its ownK242360 Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty…Dent4you AG · 2024
Most influential descendants
Showing 1 of 1 · See all- K242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal…Dent4you AG · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −4 | K973782 | Aquasil XLV Smart Wetting Impression Material | Dentsply Intl. | 1997 | — |
| −3 | K021410 | Aquasil Ultra XLV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −2 | K113406 | Aquasil Ultra Smart Wetting Impression Material | Dentsply International, Inc. | 2012 | — |
| −1 | K152861 | Aquasil Ultra + Smart Wetting Impression Material | Dentply International, Inc. | 2016 | — |
| 0 (this device) | K220097 | PRESIDENT The Original | Coltène/Whaledent AG | 2022 | — |
| +1 | K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex… | Dent4you AG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ELW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ELW device
- #1 K254152 Dia-X Sil Light Bodyscore 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K811767 | Coltene President Impression MaterialsSummary page 4…ch consists of addition type silicone based dental impression materials. PRESIDENT The Original is the relaunch and improved version of the predecessor device PRESIDENT (K811767), which is on the market since 1981. PRESIDENT The Original is a two base system consisting of base and catalyst that are mixed… | 1981 |
| * | K152861 | Aquasil Ultra + Smart Wetting Impression MaterialSummary page 6…pression material for pick-up impression in the double mix technique • Tray material for corrective impression technique 5.7 Primary predicate device Aquasil® Ultra+ (K152861) by Dentsply Sirona The primary predicate device chosen is Aquasil® Ultra+ by Dentsply Sirona. Aquasil® Ultra+ was cleared in Ma… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal… | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K242360 (Dent4you AG, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · ELW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELW
98in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELW
3in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELW
22in 2025
MAUDE reports naming product code ELW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 60 | 0 | 9 |
| 2008 | 11 | 30 | 0 | 17 |
| 2009 | 7 | 43 | 0 | 7 |
| 2010 | 5 | 88 | 1 | 16 |
| 2011 | 9 | 83 | 0 | 15 |
| 2012 | 7 | 87 | 1 | 14 |
| 2013 | 5 | 67 | 3 | 32 |
| 2014 | 11 | 122 | 0 | 35 |
| 2015 | 8 | 93 | 0 | 18 |
| 2016 | 7 | 166 | 3 | 15 |
| 2017 | 3 | 89 | 0 | 17 |
| 2018 | 5 | 126 | 0 | 14 |
| 2019 | 2 | — | 0 | 24 |
| 2020 | 4 | 99 | 0 | 8 |
| 2021 | 3 | 76 | 0 | 6 |
| 2022 | 7 | 60 | 0 | 9 |
| 2023 | 2 | — | 0 | 13 |
| 2024 | 3 | 98 | 0 | 3 |
| 2025 | 2 | — | 0 | 22 |
| 2026 | 3 | 268 | 0 | — |
What is it indicated for?
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…
Read the full statement (133 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220097: PRESIDENT The Original.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220097
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026