510(k) Report

510(k) · Cleared

Cleared

Aquasil Rigid Smart Wetting Impression Material

K970433510(k) TraditionalCleared Mar 27, 199750-day reviewClass II21 CFR 872.3660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dentsply Intl. · ELW Material, Impression

Cleared on Mar 27, 1997 as substantially equivalent to K943574 (Dentsply Intl., 1994) after a 50-day review. Its family tree reaches back 1 generation to 1994. 28 later devices descend from it.

Decided
Mar 27, 1997
Review
50 days
Class
Class II
Product code
ELW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K943574 (1994). 28 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2010: 1 descendant cleared2014: 1 descendant cleared2012: 1 descendant cleared2008: 1 descendant cleared2011: 1 descendant cleared2009: 3 descendants cleared2016: 4 descendants cleared2015: 1 descendant cleared2017: 1 descendant cleared2022: 4 descendants cleared2024: 2 descendants cleared2020: 2 descendants cleared2018: 1 descendant cleared2021: 2 descendants cleared2026: 2 descendants clearedReference device: K781151 · Reprosil · Dentsply Intl. · 1978K943574 · Capture Impression Material · Dentsply Intl. · 19941990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 9 descendants4 generations forward: 9 descendants5 generations forward: 5 descendants K943574 · Capture Impression Material · Dentsply Intl. · 19940+5
  1. Root · 1 generation backK943574 Capture Impression MaterialDentsply Intl. · 1994
  2. This deviceK970433 Aquasil Rigid Smart Wetting Impression MaterialDentsply Intl. · 1997
  3. Descendant · cites it directly · 27 of its ownK021413 Aquasil Ultra Rigid Smart Wetting Impression MaterialDentsply Intl. · 2002
  4. Descendant · 2 generations on · 17 of its ownK082560 Panasil Impression Materials, Including Putty, Binetics, Tray…Kettenbach GmbH & Co. KG · 2008
  5. Descendant · 2 generations on · 13 of its ownK103164 Vonflex Heavy, Vinflex LightVericom Co., Ltd. · 2010
  6. Descendant · 3 generations on · 12 of its ownK152766 CharmFlexDentkist, Inc. · 2016
  7. Descendant · 2 generations on · 12 of its ownK133527 Suflex Putty, Suflex Heavy, Suflex Mono, Suflex LightOsstem Germany GmbH · 2014

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2002: 12008: 12009: 32010: 12011: 12012: 12014: 12015: 12016: 42017: 12018: 12020: 22021: 22022: 42024: 22026: 2
2002high 4 (2016) · low 0 (2003)2026

Most influential descendants

Showing 5 of 28 · See all
  • K021413Aquasil Ultra Rigid Smart Wetting Impression MaterialDentsply Intl. · 2002 · cites it directly27descendants
  • K082560Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and ContactKettenbach GmbH & Co. KG · 2008 · 2 generations on17descendants
  • K103164Vonflex Heavy, Vinflex LightVericom Co., Ltd. · 2010 · 2 generations on13descendants
  • K152766CharmFlexDentkist, Inc. · 2016 · 3 generations on12descendants
  • K133527Suflex Putty, Suflex Heavy, Suflex Mono, Suflex LightOsstem Germany GmbH · 2014 · 2 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K943574Capture Impression MaterialDentsply Intl.1994—
0 (this device)K970433Aquasil Rigid Smart Wetting Impression MaterialDentsply Intl.1997—
+1K021413Aquasil Ultra Rigid Smart Wetting Impression MaterialDentsply Intl.2002—
+2K082560Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and…Kettenbach GmbH & Co. KG2008—
+2K103164Vonflex Heavy, Vinflex LightVericom Co., Ltd.2010—
+3K152766CharmFlexDentkist, Inc.2016—
+2K133527Suflex Putty, Suflex Heavy, Suflex Mono, Suflex LightOsstem Germany GmbH2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200810
200930
201010
201110
201210
201410
201510
201640
201710
201810
202020
202120
202240
202420
202620
FIG. 1 — Lineage of K970433, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K254152 Dia-X Sil Light Bodyscore 14.1 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K943574Capture Impression Material
Summary page 1
…1997 TRADE NAME: AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL CLASSIFICATION NAME: Impression Material PREDICATE DEVICE: AquaSil™ Smart Wetting Impression Material K943574 DEVICE DESCRIPTION: AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL is a two-part (base/catalyst) hydrophilic vinylpolysiloxane…
Dentsply Intl.1994—
†K781151ReprosilDentsply Intl.1978—

Also cleared against K943574: 3 other devices →

What descends from it? (28)

See all 28

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K021413Aquasil Ultra Rigid Smart Wetting Impression MaterialDentsply Intl.200227

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?

  • Its one ancestor has no recall.
  • Of its descendants, K021413 (Dentsply Intl., 2002) has gone furthest, with 27 descendants of its own.
  • 3 other devices also cite its predicate K943574.

How does its category compare?

All ELW devices

ELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ELW

2in 2025

2007: 72008: 112009: 72010: 52011: 92012: 72013: 52014: 112015: 82016: 72017: 32018: 52019: 22020: 42021: 32022: 72023: 22024: 32025: 22026 (partial year): 3
2007high 11 (2008) · low 2 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ELW

98in 2024

2007: 60 days median2008: 30 days median2009: 43 days median2010: 88 days median2011: 83 days median2012: 87 days median2013: 67 days median2014: 122 days median2015: 93 days median2016: 166 days median2017: 89 days median2018: 126 days median2020: 99 days median2021: 76 days median2022: 60 days median2024: 98 days median2026 (partial year): 268 days median
2007high 268 (2026) · low 30 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ELW

3in 2016

2010: 12012: 12013: 32016: 3
2007high 3 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ELW

22in 2025

2007: 92008: 172009: 72010: 162011: 152012: 142013: 322014: 352015: 182016: 152017: 172018: 142019: 242020: 82021: 62022: 92023: 132024: 32025: 22
2007high 35 (2014) · low 3 (2024)2025

MAUDE reports naming product code ELW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200776009
20081130017
200974307
2010588116
2011983015
2012787114
2013567332
201411122035
2015893018
20167166315
2017389017
20185126014
20192—024
202049908
202137606
202276009
20232—013
202439803
20252—022
202632680—

What is it indicated for?

AQUASIL™ RIGID Regular Set SMART WETTING IMPRESSION MATERIAL is designed as a firm tray material. It is designed to be used with Aquasil™ LV (light viscosity) Impression Material (K943574) in a dual phase impression Technique. The combination is ideal for the double arch (Caulk® First Bite™ Trays) dual phase technique. The combination may alseo be used for precise duplications of models. AQUASIL™ RIGID Fast Set SMART WETTING IMPRESSION MATERIAL is…

Read the full statement (127 words)

AQUASIL™ RIGID Regular Set SMART WETTING IMPRESSION MATERIAL is designed as a firm tray material. It is designed to be used with Aquasil™ LV (light viscosity) Impression Material (K943574) in a dual phase impression Technique. The combination is ideal for the double arch (Caulk® First Bite™ Trays) dual phase technique. The combination may alseo be used for precise duplications of models.

AQUASIL™ RIGID Fast Set SMART WETTING IMPRESSION MATERIAL is designed as a firm tray material. It is designed to be used with Aquasil™ LV Fast Set Impression Material in a dual phase impression Technique, capturing one or two adjacent preparations. The combination is ideal for the double arch (Caulk® First Bite™ Trays) dual phase technique. The combination may also be used for precise duplications of models.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K943574

3 other devices cite the same predicate.

  • K021416Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression MaterialDentsply Intl. · 2002
  • K973781Aquasil Easy Mix Putty Impression MaterialDentsply Intl. · 1997
  • K973782Aquasil XLV Smart Wetting Impression MaterialDentsply Intl. · 1997

More from Dentsply Intl.

279 FDA decisions under this applicant name. See the company

  • K123615Iris - High Strength Glass CeramicDentsply Intl. · 2013
  • K072730Friadent Cercon and Ankylos Cercon Balance AbutmentsDentsply Intl. · 2008
  • K070538XP Bond Dual Cure Universal Total Etch AdhesiveDentsply Intl. · 2007
  • K070019Carrara VolumiaDentsply Intl. · 2007
  • K061427Pre-Impression Conditioning SolutionDentsply Intl. · 2006

Recent decisions in ELW

The ELW category page

  • K254142Dia-X Sil Heavy BodyDiaDent Group International · 2026
  • K254152Dia-X Sil Light BodyDiaDent Group International · 2026
  • K254112Dia-X Sil BiteDiaDent Group International · 2026
  • K253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327)…Vigodent Indústria E Comercio Ltda · 2025
  • K250969Jet Bite; Jet Blue Bite Fast; Jet Blue Bite SuperfastDent4you AG · 2025

https://510kreport.com/device/K970433 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970433: Aquasil Rigid Smart Wetting Impression Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970433

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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