510(k) Report

FDA applicant

Dentalis Bio Solution Implants, LLC

Indianapolis, IN1 decision2017–20170 recalls

FDA records 1 decision for Dentalis Bio Solution Implants, LLC (Indianapolis, IN) in 2017: 1 510(k) clearance. All are in product code 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 Dentalis Bio Solution Implants, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Dentalis Bio Solution Implants, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form1decision

What has FDA decided for it lately?

  • K161281Dentalis Bio Solution ImplantsDentalis Bio Solution Implants, LLC · 2017

The one decision as Dentalis Bio Solution Implants, LLC →