Cleared Traditional

PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT

K881890 · Specialites Septodont · Dental
Jul 1988
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K881890 is an FDA 510(k) clearance for the PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on July 15, 1988, 71 days after receiving the submission on May 5, 1988. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K881890 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 1988
Decision Date July 15, 1988
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

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