Cleared Traditional

K972445 - PULPDENT OX-OUT
(FDA 510(k) Clearance)

K972445 · Pulpdent Corp. · Dental
Oct 1997
Decision
94d
Days
Class 2
Risk

K972445 is an FDA 510(k) clearance for the PULPDENT OX-OUT. 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 October 2, 1997, 94 days after receiving the submission on June 30, 1997.

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

Submission Details

510(k) Number K972445 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 1997
Decision Date October 02, 1997
Days to Decision 94 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