Cleared Traditional

K974014 - PULPDENT DENTASTIC UNO
(FDA 510(k) Clearance)

K974014 · Pulpdent Corp. · Dental
Dec 1997
Decision
56d
Days
Class 2
Risk

K974014 is an FDA 510(k) clearance for the PULPDENT DENTASTIC UNO. 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 December 17, 1997, 56 days after receiving the submission on October 22, 1997.

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

Submission Details

510(k) Number K974014 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 1997
Decision Date December 17, 1997
Days to Decision 56 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