510(k) Report

FDA applicant

Oral-B Laboratories

Redwood City, CA8 decisions1988–19950 recalls

FDA records 8 decisions for Oral-B Laboratories (Redwood City, CA) from 1988 to 1995: 8 510(k) clearances. Most are in product codes JES (Floss, Dental) and JET (Pick, Massaging). 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 Oral-B Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oral-B Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Oral-B Laboratories by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Oral-B”

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