Cleared Traditional

K953301 - DENTASTIC ONE-STEP
(FDA 510(k) Clearance)

K953301 · Pulpdent Corp. · Dental
Aug 1995
Decision
42d
Days
Class 2
Risk

K953301 is an FDA 510(k) clearance for the DENTASTIC ONE-STEP. 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, 42 days after receiving the submission on July 14, 1995.

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

Submission Details

510(k) Number K953301 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1995
Decision Date August 25, 1995
Days to Decision 42 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