510(k) · Cleared
ClearedPre-Impression Conditioning Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · ELW Material, Impression
Cleared on Jun 26, 2006 as substantially equivalent to K023776 (Dentsply Intl., 2003) and 3 other predicates after a 34-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Jun 26, 2006
- Review
- 34 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K931812 (1993). 15 ancestors in all, the oldest K781151 (1978). No later device cites it as a predicate yet.
- Root · 6 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 5 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 4 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 3 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 2 generations backK982394 Prime & Bond NT Dual Cure Universal Dental Adhesive SystemDentsply Intl. · 1998
- 1 generation backK023776 Xeno Iii Dental AdhesiveDentsply Intl. · 2003
- This deviceK061427 Pre-Impression Conditioning SolutionDentsply Intl. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −5 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −4 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −3 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −2 | K982394 | Prime & Bond NT Dual Cure Universal Dental Adhesive System | Dentsply Intl. | 1998 | — |
| −1 | K023776 | Xeno Iii Dental Adhesive | Dentsply Intl. | 2003 | — |
| 0 (this device) | K061427 | Pre-Impression Conditioning Solution | Dentsply Intl. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 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? (4)
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 |
|---|---|---|---|
| * | K023776 | Xeno Iii Dental AdhesiveSummary page 1…NING SOLUTION CLASSIFICATION NAME: Impression material, 872.3660 PREDICATE DEVICES: Xeno® III Dental Adhesive, K023776 Nupro® Prophylaxis Paste, K983966 Pretrea… | 2003 |
| * | K983966 | Nupro Prophylaxis Paste with Flouride and TriclosanSummary page 1…material, 872.3660 PREDICATE DEVICES: Xeno® III Dental Adhesive, K023776 Nupro® Prophylaxis Paste, K983966 Pretreatment Solution, K940685 Aquasil Ea… | 1999 |
| * | K940685 | Pretreatment SolutionSummary page 1…Dental Adhesive, K023776 Nupro® Prophylaxis Paste, K983966 Pretreatment Solution, K940685 Aquasil Easy Mix Putty Impression Material, K973781 DEVICE DESCRIPTION: The PRE-IMP… | 1994 |
| * | K973781 | Aquasil Easy Mix Putty Impression MaterialSummary page 1…983966 Pretreatment Solution, K940685 Aquasil Easy Mix Putty Impression Material, K973781 DEVICE DESCRIPTION: The PRE-IMPRESSION CONDITIONING Solution is a product to be used in the impression- taking process. When ap… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 1 company; a new generation was cleared every 2.8 years on median.
- None of the 15 ancestors has a recall.
- 1 other device also cites its predicate K023776.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Preparation conditioning solution for uniform surface wetting prior to elastomeric impression procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061427: Pre-Impression Conditioning Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061427
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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