510(k) Report

FDA applicant

Saremco Dental AG

Rebstein, CH4 decisions2022–20250 recalls

FDA records 4 decisions for Saremco Dental AG (Rebstein, CH) from 2022 to 2025: 4 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and KLE (Agent, Tooth Bonding, Resin). Since 2016 its 510(k)s took a median of 117 days from receipt to decision, against 104 for FDA’s reviews in the same codes and years. Its devices cite 6 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 Saremco Dental AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 12023: 12024: 12025: 1
2022high 1 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Saremco Dental AG by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Saremco Dental AG’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?

  • EBFMaterial, Tooth Shade, Resin3decisions
  • KLEAgent, Tooth Bonding, Resin1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 117 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 104 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K213343Saremco Print CROWNTECSaremco Dental AG · 20223cite it

What has FDA decided for it lately?

  • K252151els unibondSaremco Dental AG · 2025
  • K240823els extra low shrinkage® composite & els extra low shrinkage® flowSaremco Dental AG · 2024
  • K232050saremco print BRIDGETECSaremco Dental AG · 2023
  • K213343Saremco Print CROWNTECSaremco Dental AG · 2022

All 4 as Saremco Dental AG →