510(k) Report

510(k) · Cleared

Cleared

MARK3

K141092510(k) TraditionalCleared Dec 4, 2014220-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

Cavex Holland BV · ELW Material, Impression

Cleared on Dec 4, 2014 as substantially equivalent to K981970 (Cavex Holland BV, 1998) and 5 other predicates after a 220-day review. Its family tree reaches back 1 generation to 1998.

Decided
Dec 4, 2014
Review
220 days
Class
Class II
Product code
ELW
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K981970 (1998). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2003: 1 other ancestor2002: 1 other ancestor2001: 2 other ancestorsK981970 · Algetral, Cavex Chromatic, CA 37 Superior Pink, CA 37 Fast Set, Cavex Rainbow, Cavex Impressional Normal Setting, Cavexi · Cavex Holland BV · 199819952000200520102015
Other ancestors, by generation 1 generation back: 5 other ancestors K981970 · Algetral, Cavex Chromatic, CA 37 Superior Pink, CA 37 Fast Set, Cavex Rainbow, Cavex Impressional Normal Setting, Cavexi · Cavex Holland BV · 19980
  1. Root · 1 generation backK981970 Algetral, Cavex Chromatic, CA 37 Superior Pink, CA 37 Fast Set…Cavex Holland BV · 1998
  2. This deviceK141092 MARK3Cavex Holland BV · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K981970Algetral, Cavex Chromatic, CA 37 Superior Pink, CA 37 Fast Set, Cavex Rainbow…Cavex Holland BV1998—
0 (this device)K141092MARK3Cavex Holland BV2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120
200210
200310
200510
FIG. 1 — Lineage of K141092, 1998–2014Source: 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? (6)

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
*K981970Algetral, Cavex Chromatic, CA 37 Superior Pink, CA 37 Fast Set, Cavex Rainbow, Cavex…
Summary page 4
…Bryan Markiet 135N Rt. 9w, Congers, NY 10920, USA Phone: 845-2672600 Mark3 Alginate Impression Material Impression Material Material, Impression CFR 872.3660 ELW K981970 K011419, K051207, K013336, K023466, K032116 MARKS alginate impression material is a dust free alginate impression material with…
Cavex Holland BV1998—
*K011419Cavex Colorchange
Summary page 4
…rkiet 135N Rt. 9w, Congers, NY 10920, USA Phone: 845-2672600 Mark3 Alginate Impression Material Impression Material Material, Impression CFR 872.3660 ELW K981970 K011419, K051207, K013336, K023466, K032116 MARKS alginate impression material is a dust free alginate impression material with a creamy…
Cavex Holland BV2001—
*K051207Cavex Orthotrace
Summary page 4
…5N Rt. 9w, Congers, NY 10920, USA Phone: 845-2672600 Mark3 Alginate Impression Material Impression Material Material, Impression CFR 872.3660 ELW K981970 K011419, K051207, K013336, K023466, K032116 MARKS alginate impression material is a dust free alginate impression material with a creamy consiste…
Cavex Holland BV2005—
*K013336Xantalgin Crono
Summary page 4
…, Congers, NY 10920, USA Phone: 845-2672600 Mark3 Alginate Impression Material Impression Material Material, Impression CFR 872.3660 ELW K981970 K011419, K051207, K013336, K023466, K032116 MARKS alginate impression material is a dust free alginate impression material with a creamy consistency for g…
Cavex Holland BV2001—
*K023466Tulip Alginate Impression Material
Summary page 4
…, NY 10920, USA Phone: 845-2672600 Mark3 Alginate Impression Material Impression Material Material, Impression CFR 872.3660 ELW K981970 K011419, K051207, K013336, K023466, K032116 MARKS alginate impression material is a dust free alginate impression material with a creamy consistency for general de…
Cavex Holland BV2002—
*K032116Tulip Colorswitch
Summary page 4
…0, USA Phone: 845-2672600 Mark3 Alginate Impression Material Impression Material Material, Impression CFR 872.3660 ELW K981970 K011419, K051207, K013336, K023466, K032116 MARKS alginate impression material is a dust free alginate impression material with a creamy consistency for general dental prac…
Cavex Holland BV2003—

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?

  • None of the 6 ancestors has a recall.

How does its category compare?

All ELW devices

ELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

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?

MARK3 is an irreversible hydrocolloid dental impression material used by the dentist

for taking impressions of the oral cavity with the purpose of constructing a gypsum

cast that is a copy of the situation in the mouth. It is a general purpose impression

materials for making study models, first impressions for the construction of individual

trays, situation models, orthodontic impressions.

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

More from Cavex Holland BV

26 FDA decisions under this applicant name. See the company

  • K151535Cavex Cream AlginateCavex Holland BV · 2015
  • K073539Provisa CemCavex Holland BV · 2008
  • K072245Emulate AdvancedCavex Holland BV · 2007
  • K062400Impressix, Colorchange AlginateCavex Holland BV · 2006
  • K061267Simulate, Color Change AlginateCavex Holland BV · 2006

Recent decisions in ELW

The ELW category page

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  • 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
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https://510kreport.com/device/K141092 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141092: MARK3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141092

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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