510(k) Report

FDA applicant

3M Espe Dental Products

St. Paul, MN12 decisions2006–20231 recall

FDA records 12 decisions for 3M Espe Dental Products (St. Paul, MN) from 2006 to 2023: 12 510(k) clearances. Most are in product codes EMA (Cement, Dental) and EBF (Material, Tooth Shade, Resin). Since 2016 its 510(k)s took a median of 16 days from receipt to decision, against 159 for FDA’s reviews in the same codes and years. Its devices cite 27 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided 3M Espe Dental Products’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2007: 12008: 12010: 12011: 22012: 12014: 12019: 22023: 2
2007high 2 (2011) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — 3M Espe Dental Products by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 3M Espe Dental Products’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EMACement, Dental4decisions
  • EBFMaterial, Tooth Shade, Resin4decisions
  • LBHVarnish, Cavity2decisions
  • KLEAgent, Tooth Bonding, Resin1decision
  • EJKLiner, Cavity, Calcium Hydroxide1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 16 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 159 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 27 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 32 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K092141Vanish Varnish, 5% Sodium Fluoride White Varnish3M Espe Dental Products · 20107cite it
  • K120453Filtek Bulk Fill Flowable Restorative3M Espe Dental Products · 20126cite it
  • K111185Relyx Luting Plus Automix3M Espe Dental Products · 20115cite it
  • K110131Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative3M Espe Dental Products · 20115cite it
  • K1834763M Filtek Universal Restorative3M Espe Dental Products · 20193cite it
  • K141081Filtek Bulk Fill Posterior Restroative3M Espe Dental Products · 20143cite it

What has FDA decided for it lately?

  • K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment3M Espe Dental Products · 2023
  • K2302703M™ VitCal Liner/Base3M Espe Dental Products · 2023
  • K1911223M RelyX Pediatric Resin Modified Glass Ionomer Cement3M Espe Dental Products · 2019
  • K1834763M Filtek Universal Restorative3M Espe Dental Products · 2019
  • K141081Filtek Bulk Fill Posterior Restroative3M Espe Dental Products · 2014
  • K120453Filtek Bulk Fill Flowable Restorative3M Espe Dental Products · 2012
  • K111185Relyx Luting Plus Automix3M Espe Dental Products · 2011
  • K110131Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative3M Espe Dental Products · 20111 recall

All 12 as 3M Espe Dental Products →

What has been recalled?

1 recall linked to its devices; the latest:

  • K110131Block Versions Used by Dental Offices often referred to as chairside milling: Lava…Jun 15, 2015Class II