Cleared Traditional

K962747 - PULPDENT ENDODONTIC POST CEMENT KIT
(FDA 510(k) Clearance)

K962747 · Pulpdent Corp. · Dental
Sep 1996
Decision
77d
Days
Class 2
Risk

K962747 is an FDA 510(k) clearance for the PULPDENT ENDODONTIC POST CEMENT KIT. This device is classified as a Cement, Dental (Class II — Special Controls, product code EMA).

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on September 30, 1996, 77 days after receiving the submission on July 15, 1996.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K962747 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 1996
Decision Date September 30, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275