510(k) Report

FDA applicant

Otc/America

Wellesley Hills, MA2 decisions1986–19860 recalls

FDA records 2 decisions for Otc/America (Wellesley Hills, MA) in 1986: 2 510(k) clearances. Most are in product codes KMW (Handpiece, Rotary Bone Cutting) and DZE (Implant, Endosseous, Root-Form). 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 Otc/America’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Otc/America since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Otc/America 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?

  • KMWHandpiece, Rotary Bone Cutting1decision
  • DZEImplant, Endosseous, Root-Form1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K860653Pure Titanium Screw-Type for Dental ImplantOtc/America · 19861cites it

What has FDA decided for it lately?

  • K862110Osseodent Drilling SystemOtc/America · 1986
  • K860653Pure Titanium Screw-Type for Dental ImplantOtc/America · 1986

All 2 as Otc/America →