510(k) Report

FDA applicant

Pulpdent Corp. of America

Brookline, MA6 decisions1981–19880 recalls

FDA records 6 decisions for Pulpdent Corp. of America (Brookline, MA) from 1981 to 1988: 6 510(k) clearances. Most are in product codes EMA (Cement, Dental) and ELW (Material, Impression). 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 Pulpdent Corp. of America’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pulpdent Corp. of America since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pulpdent Corp. of America by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Pulpdent”

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