510(k) Report

FDA applicant

Dental Morelli

Aventura, FL2 decisions2013–20140 recalls

FDA records 2 decisions for Dental Morelli (Aventura, FL) from 2013 to 2014: 2 510(k) clearances. Most are in product codes OAT (Implant, Endosseous, Orthodontic) and NJM (Bracket, Ceramic, Orthodontic). Its devices cite 2 predicates, 0 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 Dental Morelli’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2013: 12014: 1
2013high 1 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Dental Morelli 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?

  • OATImplant, Endosseous, Orthodontic1decision
  • NJMBracket, Ceramic, Orthodontic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K130476Orthodontic Miniscrew for Absolute AnchorageDental Morelli · 2014
  • K131197Edgewise Ceramic Brackets, Roth Ceramic BracketsDental Morelli · 2013

All 2 as Dental Morelli →