Cleared Traditional

K953272 - PULPDENT DENTASTIC II
(FDA 510(k) Clearance)

K953272 · Pulpdent Corp. · Dental
Aug 1995
Decision
43d
Days
Class 2
Risk

K953272 is an FDA 510(k) clearance for the PULPDENT DENTASTIC II. 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 August 25, 1995, 43 days after receiving the submission on July 13, 1995.

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

Submission Details

510(k) Number K953272 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1995
Decision Date August 25, 1995
Days to Decision 43 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