Cleared Traditional

CIMPAT S TEMPORARY DENTAL CEMENT

K885007 · Specialites Septodont · Dental
Mar 1989
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K885007 is an FDA 510(k) clearance for the CIMPAT S TEMPORARY 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 March 1, 1989, 90 days after receiving the submission on December 1, 1988. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K885007 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1988
Decision Date March 01, 1989
Days to Decision 90 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