510(k) Report

FDA applicant

Dentscare Ltda

Joinville, BR10 decisions2019–20240 recalls

FDA records 10 decisions for Dentscare Ltda (Joinville, BR) from 2019 to 2024: 10 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EBG (Crown And Bridge, Temporary, Resin). Since 2016 its 510(k)s took a median of 300 days from receipt to decision, against 152 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 2 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 Dentscare Ltda’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2019: 42020: 32021: 12024: 2
2019high 4 (2019) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Dentscare Ltda by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EBFMaterial, Tooth Shade, Resin6decisions
  • EBGCrown And Bridge, Temporary, Resin1decision
  • DYHAdhesive, Bracket And Tooth Conditioner, Resin1decision
  • EMACement, Dental1decision
  • KLEAgent, Tooth Bonding, Resin1decision

How long do its 510(k) reviews take?

Since 2016, its 10 510(k)s took a median of 300 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 152 days; 1 of its 10 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 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.

  • K201707Opallis, Opallis FlowDentscare Ltda · 20202cite it
  • K192682Orthocem, Ortho BiteDentscare Ltda · 20201cites it
  • K191306Llis, Vittra APSDentscare Ltda · 20191cites it

What has FDA decided for it lately?

  • K231859PrimmaArtDentscare Ltda · 2024
  • K232994Vittra APS Unique FlowDentscare Ltda · 2024
  • K210231Vittra APS UniqueDentscare Ltda · 2021
  • K201707Opallis, Opallis FlowDentscare Ltda · 2020
  • K192682Orthocem, Ortho BiteDentscare Ltda · 2020
  • K191389Allcem Veneer APSDentscare Ltda · 2020
  • K191306Llis, Vittra APSDentscare Ltda · 2019
  • K183424Ambar, Ambar APS, Ambar Universal APSDentscare Ltda · 2019

All 10 as Dentscare Ltda →