510(k) Report

FDA applicant

Professional Dental Mfg., Inc.

Batesville, AR2 decisions1997–19980 recalls

FDA records 2 decisions for Professional Dental Mfg., Inc. (Batesville, AR) from 1997 to 1998: 2 510(k) clearances. Most are in product codes EFB (Handpiece, Air-Powered, Dental) and ELC (Scaler, Ultrasonic). 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 Professional Dental Mfg., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Professional Dental Mfg., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Professional Dental Mfg., 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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Other applicant names beginning “Professional”

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