510(k) Report

FDA applicant

Itena Clinical

Laval, CA8 decisions2013–20170 recalls

FDA records 8 decisions for Itena Clinical (Laval, CA) from 2013 to 2017: 8 510(k) clearances. Most are in product codes EMA (Cement, Dental) and KIF (Resin, Root Canal Filling). Its devices cite 13 predicates, 1 of them its own earlier devices. No 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 Itena Clinical’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2013: 62017: 2
2013high 6 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Itena Clinical by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EMACement, Dental4decisions
  • KIFResin, Root Canal Filling1decision
  • KLEAgent, Tooth Bonding, Resin1decision
  • EBCSealant, Pit And Fissure, And Conditioner1decision
  • EBFMaterial, Tooth Shade, Resin1decision

Whose devices does it build on?

Its devices cite 13 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K122521Prevent SealItena Clinical · 20131cites it
  • K121804Provitemp, Dentotemp, Totalcem, DentocemItena Clinical · 20131cites it

What has FDA decided for it lately?

  • K170207ObturysItena Clinical · 2017
  • K162960TotalC-RamItena Clinical · 2017
  • K122551ProvitempItena Clinical · 2013
  • K122521Prevent SealItena Clinical · 2013
  • K122549Dento TempItena Clinical · 2013
  • K121804Provitemp, Dentotemp, Totalcem, DentocemItena Clinical · 2013
  • K122522Dentoetch Quickbond Bond ActivatorItena Clinical · 2013
  • K121769Dentocore / Dentocore BodyItena Clinical · 2013

All 8 as Itena Clinical →