510(k) Report

510(k) · Cleared

Cleared

Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One

K260783510(k) TraditionalCleared Mar 11, 20261-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

Kulzer, LLC · EBF Material, Tooth Shade, Resin

Cleared on Mar 11, 2026 as substantially equivalent to K073554 (Heraeus Kulzer,GmbH, 2008) and 3 other predicates after a 1-day review. Its family tree reaches back 2 generations to 2008.

Decided
Mar 11, 2026
Review
1 day
Class
Class II
Product code
EBF
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K083610 (2008). 5 ancestors in all, the oldest K073554 (2008). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2022: 1 other ancestor2009: 1 other ancestor2008: 1 other ancestorReference device: K231817 · AlignerFlow LC · Voco GmbH · 2023Reference device: K150128 · GC Ortho Connect, GC Ortho Etching Gel · Gc Orthodontics America, Inc. · 2015K083610 · Filtek Supreme Ultra Universal Restorative · 3M Company · 2008K112501 · Venus Pearl PLT Refill A1 · Heraeus Kulzer, LLC · 201120052010201520202025
Other ancestors, by generation 1 generation back: 3 other ancestors K112501 · Venus Pearl PLT Refill A1 · Heraeus Kulzer, LLC · 2011K083610 · Filtek Supreme Ultra Universal Restorative · 3M Company · 20080
  1. Root · 2 generations backK083610 Filtek Supreme Ultra Universal Restorative3M Company · 2008
  2. 1 generation backK112501 Venus Pearl PLT Refill A1Heraeus Kulzer, LLC · 2011
  3. This deviceK260783 Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneKulzer, LLC · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K083610Filtek Supreme Ultra Universal Restorative3M Company2008—
−1K112501Venus Pearl PLT Refill A1Heraeus Kulzer, LLC2011—
0 (this device)K260783Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneKulzer, LLC2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
202210
FIG. 1 — Lineage of K260783, 2008–2026Source: 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 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? (4)

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
*K073554NEUN
Summary page 9
…Page 9 === 2 Legally Marketed Predicate Devices For the purpose of substantial equivalence, the following primary predicates apply: • Venus Diamond -> Neun (K073554) • Venus Diamond Flow -> Venus Diamond Flow (K091635) • Venus Pearl -> Venus Pearl PLT A1 (K112501) • Venus…
Heraeus Kulzer,GmbH2008—
*K091635Venus Diamond Flow
Summary page 9
…purpose of substantial equivalence, the following primary predicates apply: • Venus Diamond -> Neun (K073554) • Venus Diamond Flow -> Venus Diamond Flow (K091635) • Venus Pearl -> Venus Pearl PLT A1 (K112501) • Venus Bulk Flow ONE -> Venus Bulk Flow ONE (K220605) Reference…
Heraeus Kulzer, LLC2009—
*K112501Venus Pearl PLT Refill A1
Summary page 9
…imary predicates apply: • Venus Diamond -> Neun (K073554) • Venus Diamond Flow -> Venus Diamond Flow (K091635) • Venus Pearl -> Venus Pearl PLT A1 (K112501) • Venus Bulk Flow ONE -> Venus Bulk Flow ONE (K220605) Reference Devices Used to support methods/benchmarks for align…
Heraeus Kulzer, LLC2011—
*K220605Venus Bulk Flow ONE
Summary page 9
…54) • Venus Diamond Flow -> Venus Diamond Flow (K091635) • Venus Pearl -> Venus Pearl PLT A1 (K112501) • Venus Bulk Flow ONE -> Venus Bulk Flow ONE (K220605) Reference Devices Used to support methods/benchmarks for aligner-related indications: • AlignerFlow LC (K231817) – D…
Kulzer, LLC2022—
†K231817AlignerFlow LCVoco GmbH2023—
†K150128GC Ortho Connect, GC Ortho Etching GelGc Orthodontics America, Inc.2015—

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?

  • The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 14.2 years on median.
  • None of the 5 ancestors has a recall.

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. 2026, this device’s year, is highlighted.

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—

What is it indicated for?

• Class I, II, III, IV and V direct restorations • First-layer lining for class I and II cavities • Repair of direct and indirect restorations in combination with a suitable adhesive • Splinting of teeth • Extended fissure sealing • Composite attachments for aligner treatment • Fixation of retainers * Enlarged fissure sealing * Cavity lining — as the first layer for Class I and II cavities e Class I, II, III, IV and V direct restorations * Small repairs…

Read the full statement (218 words)

• Class I, II, III, IV and V direct restorations

• First-layer lining for class I and II cavities

• Repair of direct and indirect restorations in combination with a suitable adhesive

• Splinting of teeth

• Extended fissure sealing

• Composite attachments for aligner treatment

• Fixation of retainers

* Enlarged fissure sealing

* Cavity lining — as the first layer for Class I and II cavities

e Class I, II, III, IV and V direct restorations

* Small repairs of direct and indirect restorations combined with a suitable bonding agent

* Splinting of teeth

» Composite attachments for aligner treatment

» Fixation of retainers

* Direct restorations of all cavity classes

* Direct composite veneers

» Shape corrections of teeth (i.e. diastemas, congenital defects in teeth, etc.)

* Splinting of teeth

* Restoration of primary teeth

* Core build-up

* Repairs of porcelain, composite (in combination with an adequate repair-system)

» Composite attachments for aligner treatment

» Fixation of retainers

* Direct restorations of all cavity classes

* Direct composite veneers

» Shape corrections of teeth (i.e. diastemas, congenital defects in teeth, etc.)

* Splinting of teeth

* Restoration of primary teeth

* Core build-up

* Repairs of porcelain, composite (in combination with an adequate repair-system)

» Composite attachments for aligner treatment

» Fixation of retainers

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

More from Kulzer, LLC

7 FDA decisions under this applicant name. See the company

  • K254063iCEM Universal PlusKulzer, LLC · 2025
  • K243910RetraxilKulzer, LLC · 2025
  • K240660Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum…Kulzer, LLC · 2024
  • K233868dima Print Teeth & TempKulzer, LLC · 2024
  • K230644Signum opaque FKulzer, LLC · 2023

Recent decisions in EBF

The EBF category page

  • K262982Core·it DualSpident Co., Ltd. · 2026
  • 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/K260783 · printed Nov 6, 2026

Cite this page

510(k) Report. “K260783: Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260783

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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