510(k) Report

510(k) · Cleared

Cleared

Liqcrylic Pro Dental Resin

K972573510(k) TraditionalCleared Sep 16, 199768-day reviewClass II21 CFR 872.3760

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

Dentsply Intl. · EBI Resin, Denture, Relining, Repairing, Rebasing

Cleared on Sep 16, 1997 as substantially equivalent to K902115 (Kulzer, Inc., 1990) after a 68-day review. Its family tree reaches back 1 generation to 1990. 62 later devices descend from it.

Decided
Sep 16, 1997
Review
68 days
Class
Class II
Product code
EBI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K902115 (1990). 62 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 3 descendants cleared2007: 4 descendants cleared2004: 1 descendant cleared2015: 5 descendants cleared2008: 1 descendant cleared2011: 3 descendants cleared2022: 6 descendants cleared2012: 1 descendant cleared2014: 2 descendants cleared2023: 4 descendants cleared2024: 4 descendants cleared2010: 1 descendant cleared2017: 3 descendants cleared2018: 1 descendant cleared2016: 2 descendants cleared2019: 4 descendants cleared2020: 3 descendants cleared2025: 5 descendants cleared2021: 2 descendants cleared2026: 6 descendants cleared2009: 1 descendant clearedK902115 · Palapress (R) Vario Resin · Kulzer, Inc. · 19901990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 5 descendants4 generations forward: 10 descendants5 generations forward: 23 descendants6 generations forward: 11 descendants7 generations forward: 7 descendants8 generations forward: 2 descendants9 generations forward: 1 descendant K902115 · Palapress (R) Vario Resin · Kulzer, Inc. · 19900+5
  1. Root · 1 generation backK902115 Palapress (R) Vario ResinKulzer, Inc. · 1990
  2. This deviceK972573 Liqcrylic Pro Dental ResinDentsply Intl. · 1997
  3. Descendant · cites it directly · 60 of its ownK990763 Vitron MEspe Dental AG · 1999
  4. Descendant · cites it directly · 60 of its ownK991220 Vitron HEspe Dental AG · 1999
  5. Descendant · 2 generations on · 59 of its ownK992645 SinfonyEspe Dental AG · 1999
  6. Descendant · 3 generations on · 35 of its ownK071131 UNO3M Espe AG Dental Products · 2007
  7. Descendant · 4 generations on · 34 of its ownK110302 Adhesive Exl-7593M Espe AG · 2011

Showing 5 of 62 descendants. See all descendants

Descendants cleared per year

1999: 32004: 12007: 42008: 12009: 12010: 12011: 32012: 12014: 22015: 52016: 22017: 32018: 12019: 42020: 32021: 22022: 62023: 42024: 42025: 52026: 6
1999high 6 (2022) · low 0 (2000)2026

Most influential descendants

Showing 5 of 62 · See all
  • K990763Vitron MEspe Dental AG · 1999 · cites it directly60descendants
  • K991220Vitron HEspe Dental AG · 1999 · cites it directly60descendants
  • K992645SinfonyEspe Dental AG · 1999 · 2 generations on59descendants
  • K071131UNO3M Espe AG Dental Products · 2007 · 3 generations on35descendants
  • K110302Adhesive Exl-7593M Espe AG · 2011 · 4 generations on34descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K902115Palapress (R) Vario ResinKulzer, Inc.1990—
0 (this device)K972573Liqcrylic Pro Dental ResinDentsply Intl.1997—
+1K990763Vitron MEspe Dental AG1999—
+1K991220Vitron HEspe Dental AG1999—
+2K992645SinfonyEspe Dental AG1999—
+3K071131UNO3M Espe AG Dental Products2007—
+4K110302Adhesive Exl-7593M Espe AG2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199930
200410
200740
200810
200910
201010
201130
201210
201420
201550
201620
201730
201810
201940
202030
202120
202260
202340
202440
202550
202660
FIG. 1 — Lineage of K972573, 1990–2026Source: 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 EBI? 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 EBI device

  1. #1 K250617 Apex Flexscore 18.3 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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
*K902115Palapress (R) Vario Resin
Summary page 1
…E OR PROPRIETARY NAME: LIQCRYLIC™ PRO DENTAL RESIN CLASSIFICATION NAME: Denture relining, repairing or rebasing resin 872.3760 PREDICATE DEVICE: Palapress Vario Resin K902115 DEVICE DESCRIPTION: LIQCRYLIC™ PRO DENTAL RESIN is a pourable, cold-curing powder and liquid polymethyl methacrylate denture bas…
Kulzer, Inc.1990—

Also cleared against K902115: 3 other devices →

What descends from it? (62)

See all 62

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K990763Vitron MEspe Dental AG199960
K991220Vitron HEspe Dental AG199960

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, K990763 (Espe Dental AG, 1999) has gone furthest, with 60 descendants of its own.
  • 3 other devices also cite its predicate K902115.

How does its category compare?

All EBI devices

EBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBI

11in 2025

2007: 102008: 62009: 32010: 42011: 112012: 32013: 52014: 52015: 92016: 72017: 82018: 52019: 42020: 62021: 42022: 112023: 112024: 92025: 112026 (partial year): 7
2007high 11 (2011) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBI

79in 2025

2007: 53 days median2008: 124 days median2009: 234 days median2010: 95 days median2011: 113 days median2012: 85 days median2013: 135 days median2014: 102 days median2015: 106 days median2016: 147 days median2017: 196 days median2018: 158 days median2019: 127 days median2020: 283 days median2021: 99 days median2022: 154 days median2023: 96 days median2024: 90 days median2025: 79 days median2026 (partial year): 87 days median
2007high 283 (2020) · low 53 (2007)2026

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

Recalls per year · EBI

2in 2022

2018: 22022: 2
2007high 2 (2018) · low 0 (2007)2026

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

Adverse event reports per year · EBI

34in 2025

2007: 72008: 22009: 52010: 42011: 62012: 92013: 52014: 92015: 82016: 92017: 22018: 22019: 102020: 82021: 252022: 22023: 132024: 12025: 34
2007high 34 (2025) · low 1 (2024)2025

MAUDE reports naming product code EBI, 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
2007105307
2008612402
2009323405
201049504
20111111306
201238509
2013513505
2014510209
2015910608
2016714709
2017819602
2018515822
20194127010
2020628308
2021499025
20221115422
20231196013
202499001
20251179034
20267870—

What is it indicated for?

Used in the fabrication, repair or rebasing of complete or partial

removable dentures and other removable dental appliances.

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

Cite this page

510(k) Report. “K972573: Liqcrylic Pro Dental Resin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972573

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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