PULPDENT CANAL FINDER— 510(k) K945811

Name: FDA 510(k) clearance K945811
Creator: U.S. Food and Drug Administration
Published: 1995-01-20

Substantially Equivalent

Pulpdent Corp.

FDA 510(k) clearance K945811 for PULPDENT CANAL FINDER, Substantially Equivalent on 1995-01-20. Applicant: Pulpdent Corp.. Device class: Unclassified.

Clearance details

Applicant: Pulpdent Corp.
Product code: Code LQY
Device class: Unclassified
Advisory panel: Unknown
Date received: 1994-11-28
Decision date: 1995-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

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K020115 — PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM2002-02-28
K014059 — PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE2002-02-27
K013411 — PULPDENT CAVITY PREPARATION IV2001-12-12

Adverse events under product code LQY

product code LQY

Malfunction: 504
Total: 504

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.