510(k) Report

FDA applicant

New Stetic

Apollo Beach, FL5 decisions2011–20260 recalls

FDA records 5 decisions for New Stetic (Apollo Beach, FL) from 2011 to 2026: 5 510(k) clearances. Most are in product codes ELM (Denture, Plastic, Teeth) and OIV (Dental Amalgam). Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “New Stetic, SA”.

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 New Stetic’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2011: 12013: 12014: 12019: 12026 (partial year): 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — New Stetic by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ELMDenture, Plastic, Teeth1decision
  • OIVDental Amalgam1decision
  • EBFMaterial, Tooth Shade, Resin1decision
  • EBIResin, Denture, Relining, Repairing, Rebasing1decision
  • EBGCrown And Bridge, Temporary, Resin1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K102874New Stetic AcrylicsNew Stetic · 20112cite it
  • K192153Portux CAD/CAM DiscNew Stetic, SA · 20191cites it

What has FDA decided for it lately?

  • K254245Zafira®New Stetic, SA · 2026
  • K192153Portux CAD/CAM DiscNew Stetic, SA · 2019
  • K140125New Stetic Dental Amalgam AlloyNew Stetic · 2014
  • K122925New Stetic Artificial TeethNew Stetic · 2013
  • K102874New Stetic AcrylicsNew Stetic · 2011

All 3 as New Stetic →All 2 as New Stetic, SA →