510(k) Report

510(k) · Cleared

Cleared

Palfique Estelite LV Clear

K010267510(k) TraditionalCleared Feb 27, 200129-day reviewClass II21 CFR 872.3690

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

Tokuyama America, Inc. · EBF Material, Tooth Shade, Resin

Cleared on Feb 27, 2001 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Feb 27, 2001
Review
29 days
Class
Class II
Product code
EBF
Recalls
None
Predicates
0

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

Descendants, by year cleared 2018: 1 descendant cleared2020: 1 descendant cleared2026: 1 descendant cleared2021: 1 descendant cleared200020052010201520202025
  1. This deviceK010267 Palfique Estelite LV ClearTokuyama America, Inc. · 2001
  2. Descendant · cites it directly · 3 of its ownK173275 OmnichromaTokuyama Dental Corporation · 2018
  3. Descendant · 2 generations on · 1 of its ownK193537 Omnichroma FlowTokuyama Dental Corporation · 2020
  4. Descendant · 2 generations on · 0 of its ownK261071 DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill…DiaDent Group International · 2026
  5. Descendant · 3 generations on · 0 of its ownK203598 Omnichroma Flow BulkTokuyama Dental Corporation · 2021

Most influential descendants

Showing 4 of 4 · See all
  • K173275OmnichromaTokuyama Dental Corporation · 2018 · cites it directly3descendants
  • K193537Omnichroma FlowTokuyama Dental Corporation · 2020 · 2 generations on1descendant
  • K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW…DiaDent Group International · 2026 · 2 generations on0descendants
  • K203598Omnichroma Flow BulkTokuyama Dental Corporation · 2021 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010267Palfique Estelite LV ClearTokuyama America, Inc.2001—
+1K173275OmnichromaTokuyama Dental Corporation2018—
+2K193537Omnichroma FlowTokuyama Dental Corporation2020—
+2K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL…DiaDent Group International2026—
+3K203598Omnichroma Flow BulkTokuyama Dental Corporation2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202010
202110
202610
FIG. 1 — Lineage of K010267, 2001–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EBF? 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 EBF device

  1. #1 K202846 Tera Harzscore 18.5 · 7 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K173275OmnichromaTokuyama Dental Corporation20183

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, K173275 (Tokuyama Dental Corporation, 2018) has gone furthest, with 3 descendants of its own.

How does its category compare?

All EBF devices

EBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBF

15in 2025

2007: 192008: 142009: 202010: 192011: 192012: 112013: 132014: 102015: 172016: 202017: 152018: 152019: 172020: 152021: 132022: 172023: 92024: 182025: 152026 (partial year): 16
2007high 20 (2009) · low 9 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBF

43in 2025

2007: 49 days median2008: 79 days median2009: 84 days median2010: 75 days median2011: 81 days median2012: 86 days median2013: 153 days median2014: 112 days median2015: 123 days median2016: 205 days median2017: 108 days median2018: 115 days median2019: 159 days median2020: 190 days median2021: 178 days median2022: 63 days median2023: 87 days median2024: 120 days median2025: 43 days median2026 (partial year): 59 days median
2007high 205 (2016) · low 43 (2025)2026

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

Recalls per year · EBF

1in 2020

2007: 12008: 422009: 12010: 62011: 72017: 42019: 22020: 12026 (partial year): 2
2007high 42 (2008) · low 0 (2012)2026

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

Adverse event reports per year · EBF

1in 2025

2007: 62008: 102009: 82010: 312011: 312012: 622013: 2462014: 1952015: 1192016: 1432017: 422018: 82019: 112020: 22021: 22022: 22023: 82024: 52025: 1
2007high 246 (2013) · low 1 (2025)2025

MAUDE reports naming product code EBF, 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
2007194916
200814794210
2009208418
20101975631
20111981731
20121186062
2013131530246
2014101120195
2015171230119
2016202050143
201715108442
20181511508
201917159211
20201519012
20211317802
2022176302
202398708
20241812005
2025154301
202616592—

More from Tokuyama America, Inc.

22 FDA decisions under this applicant name. See the company

  • K022641Tokuyama Rebase IITokuyama America, Inc. · 2002
  • K011854Tokuyama M-BondTokuyama America, Inc. · 2001
  • K011685Bistite II DCTokuyama America, Inc. · 2001
  • K002863Palfique Estelite LVTokuyama America, Inc. · 2001
  • K993917Tokuyama One-UP-Bond FTokuyama America, Inc. · 2000

Recent decisions in EBF

The EBF category page

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  • K262202Cerasmart ForteGC America, Inc. · 2026
  • K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd. · 2026
  • K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc. · 2026
  • K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc. · 2026

https://510kreport.com/device/K010267 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010267: Palfique Estelite LV Clear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010267

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026