510(k) Report

510(k) · Cleared

Cleared

Match Press Pressable Ceramic

K024250510(k) TraditionalCleared Aug 25, 2003245-day reviewClass II21 CFR 872.6660

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

Davis Schottlander & Davis, Ltd. · EIH Powder, Porcelain

Cleared on Aug 25, 2003 after a 245-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.

Decided
Aug 25, 2003
Review
245 days
Class
Class II
Product code
EIH
Recalls
None
Predicates
0

10 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2007: 1 descendant cleared2011: 1 descendant cleared2015: 1 descendant cleared2020: 2 descendants cleared2016: 1 descendant cleared2017: 1 descendant cleared2023: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK024250 Match Press Pressable CeramicDavis Schottlander & Davis, Ltd. · 2003
  2. Descendant · cites it directly · 9 of its ownK043221 Willi Geller Creation CP PorcelainJensen Industries, Inc. · 2004
  3. Descendant · 2 generations on · 8 of its ownK070114 Creation CP-ZI PorcelainJensen Industries, Inc. · 2007
  4. Descendant · 2 generations on · 7 of its ownK111743 The Insync Ceramic SystemJensen Industries, Inc. · 2011
  5. Descendant · 3 generations on · 3 of its ownK141400 Dcceram SystemCeramay GmbH & Co.Kg · 2015
  6. Descendant · 3 generations on · 1 of its ownK193588 DD ContrastDental Direkt GmbH · 2020

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2004: 12007: 12011: 12015: 12016: 12017: 12020: 22023: 12025: 1
2004high 2 (2020) · low 0 (2005)2026

Most influential descendants

Showing 5 of 10 · See all
  • K043221Willi Geller Creation CP PorcelainJensen Industries, Inc. · 2004 · cites it directly9descendants
  • K070114Creation CP-ZI PorcelainJensen Industries, Inc. · 2007 · 2 generations on8descendants
  • K111743The Insync Ceramic SystemJensen Industries, Inc. · 2011 · 2 generations on7descendants
  • K141400Dcceram SystemCeramay GmbH & Co.Kg · 2015 · 3 generations on3descendants
  • K193588DD ContrastDental Direkt GmbH · 2020 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K024250Match Press Pressable CeramicDavis Schottlander & Davis, Ltd.2003—
+1K043221Willi Geller Creation CP PorcelainJensen Industries, Inc.2004—
+2K070114Creation CP-ZI PorcelainJensen Industries, Inc.2007—
+2K111743The Insync Ceramic SystemJensen Industries, Inc.2011—
+3K141400Dcceram SystemCeramay GmbH & Co.Kg2015—
+3K193588DD ContrastDental Direkt GmbH2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200710
201110
201510
201610
201710
202020
202310
202510
FIG. 1 — Lineage of K024250, 2003–2025Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EIH? 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 EIH device

  1. #1 K192231 Dental Glass Ceramics Blocksscore 15.3 · 3 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K043221Willi Geller Creation CP PorcelainJensen Industries, Inc.20049

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?

  • Of its descendants, K043221 (Jensen Industries, Inc., 2004) has gone furthest, with 9 descendants of its own.

How does its category compare?

All EIH devices

EIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EIH

13in 2025

2007: 152008: 152009: 152010: 142011: 142012: 92013: 162014: 182015: 232016: 222017: 162018: 102019: 162020: 132021: 172022: 162023: 152024: 282025: 132026 (partial year): 14
2007high 28 (2024) · low 9 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EIH

84in 2025

2007: 63 days median2008: 87 days median2009: 79 days median2010: 89 days median2011: 80 days median2012: 96 days median2013: 107 days median2014: 118 days median2015: 118 days median2016: 187 days median2017: 149 days median2018: 139 days median2019: 125 days median2020: 155 days median2021: 131 days median2022: 89 days median2023: 114 days median2024: 89 days median2025: 84 days median2026 (partial year): 73 days median
2007high 187 (2016) · low 63 (2007)2026

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

Recalls per year · EIH

1in 2025

2016: 212025: 1
2007high 21 (2016) · low 0 (2007)2026

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

Adverse event reports per year · EIH

1in 2025

2008: 12011: 12013: 62014: 12016: 42017: 12018: 22019: 12021: 222024: 72025: 1
2007high 22 (2021) · low 0 (2007)2025

MAUDE reports naming product code EIH, 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
2007156300
2008158701
2009157900
2010148900
2011148001
201299600
20131610706
20141811801
20152311800
201622187214
20171614901
20181013902
20191612501
20201315500
202117131022
2022168900
20231511400
2024288907
2025138411
202614730—

What is it indicated for?

Match Press pressable ceramic is to be used in the construction of crown substructures to be veneered with conventional porcelain.

For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.

Indications for use as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K024250: Match Press Pressable Ceramic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024250

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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