510(k) Report

FDA applicant

Insight Dental System

San Antonio, TX1 decision2017–20170 recalls

FDA records 1 decision for Insight Dental System (San Antonio, TX) in 2017: 1 510(k) clearance. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 1 predicate, 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 Insight Dental System’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 — Insight Dental System 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

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K170211Insight Dental SystemInsight Dental System · 2017

The one decision as Insight Dental System →

Other applicant names beginning “Insight”

FDA records each applicant name separately; these may or may not be the same firm.

Insight Medical Corp. 3Insight International, Inc. 2Insight Technologies Instruments, LLC 2Insight Medical Systems, Inc. 2Insight Systems 1Insight Optical Mfg. Co. of Florida, Inc. 1Insight Instruments Mfg., Inc. 1Insight Neuroimaging Systems, LLC 1Insight Instruments, Inc. 1Insight Medbotics, Inc. 1