PULPDENT CALCIUM HYDROXIDE PREPARATIONS— 510(k) K944945

Name: FDA 510(k) clearance K944945
Creator: U.S. Food and Drug Administration
Published: 1994-11-30

Substantially Equivalent

Pulpdent Corp.

FDA 510(k) clearance K944945 for PULPDENT CALCIUM HYDROXIDE PREPARATIONS, Substantially Equivalent on 1994-11-30. Applicant: Pulpdent Corp.. Device class: 2.

Clearance details

Applicant: Pulpdent Corp.
Product code: Code EJK
Device class: Class 2
Regulation: 21 CFR 872.3250
Advisory panel: Dental
Date received: 1994-10-07
Decision date: 1994-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

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