510(k) Report

FDA applicant

Orthotech

Tampa, FL2 decisions1994–19970 recalls

FDA records 2 decisions for Orthotech (Tampa, FL) from 1994 to 1997: 2 510(k) clearances. Most are in product codes EJF (Bracket, Metal, Orthodontic) and HTY (Pin, Fixation, Smooth). 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 Orthotech’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orthotech since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Orthotech by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EJFBracket, Metal, Orthodontic1decision
  • HTYPin, Fixation, Smooth1decision

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?

  • K971453Orthotec K-Cap SystemOrthotech · 1997
  • K933080Orthotech Dura-Gold BarcketsOrthotech · 1994

All 2 as Orthotech →