510(k) Report

510(k) · Cleared

Cleared

DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)

K252035510(k) TraditionalCleared Sep 17, 202579-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

Kamemizu Chemical Industry Co., Ltd. · EBI Resin, Denture, Relining, Repairing, Rebasing

Cleared on Sep 17, 2025 as substantially equivalent to K070698 (GC America, Inc., 2007) after a 79-day review. Its family tree reaches back 1 generation to 2007.

Decided
Sep 17, 2025
Review
79 days
Class
Class II
Product code
EBI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K070698 (2007). No later device cites it as a predicate yet.

K070698 · Coe Comfort · GC America, Inc. · 200720052010201520202025
K070698 · Coe Comfort · GC America, Inc. · 20070
  1. Root · 1 generation backK070698 Coe ComfortGC America, Inc. · 2007
  2. This deviceK252035 DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE…Kamemizu Chemical Industry Co., Ltd. · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K070698Coe ComfortGC America, Inc.2007—
0 (this device)K252035DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink…Kamemizu Chemical Industry Co., Ltd.2025—
FIG. 1 — Lineage of K252035, 2007–2025Source: 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 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
*K070698Coe Comfort
Summary page 5
…3760 Product Code(s) EBI | Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) 21 CFR 807.92(a)(3) Product Code K070698 COE COMFORT EBI Device Description Summary 21 CFR 807.92(a)(4) DENTURE SOFT EX is a soft lining material for removable dentur…
GC America, Inc.2007—

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?

  • Its one ancestor has no recall.

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. 2025, this device’s year, is highlighted.

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?

It is a soft acrylic resin used to line the denture base. It is a tissue conditioner. By lining the mucous membrane side of dentures, it is used for temporary relining, tissue conditioning, and obtaining functional impressions.

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

Recent decisions in EBI

The EBI category page

  • K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc. · 2026
  • K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc. · 2026
  • K262681NanoCeram Resin3BFAB Teknoloji a.S. · 2026
  • K262300Denture Base Resin V2Formlabs Ohio, Inc. · 2026
  • K261474DENTCA Tru FlexibleDentca, Inc. · 2026

https://510kreport.com/device/K252035 · printed Nov 4, 2026

Cite this page

510(k) Report. “K252035: DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252035

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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