FDA applicant

Pulpdent Corp.

Watertown, MA110 decisions1990–20210 recalls

FDA records 110 decisions for Pulpdent Corp. (Watertown, MA) from 1990 to 2021: 110 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EMA (Cement, Dental). Its devices cite 35 predicates, 18 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Pulpdent Corporation”.

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.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007high 7 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Pulpdent”

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

Pulpdent Corp. of America 6

Pulpdent Corp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Pulpdent”