510(k) Report

FDA applicant

American Dental Technologies, Inc.

San Carlos, CA8 decisions1995–20030 recalls

FDA records 8 decisions for American Dental Technologies, Inc. (San Carlos, CA) from 1995 to 2003: 8 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and EIA (Unit, Operative Dental). Its devices cite 7 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, general and plastic surgery panel, where it files most

How often FDA has decided American Dental Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Dental Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like American Dental Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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