Cleared Traditional

K885007 - CIMPAT S TEMPORARY DENTAL CEMENT

K885007 is the FDA 510(k) clearance for CIMPAT S TEMPORARY DENTAL CEMENT by Specialites Septodont. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K885007 · Specialites Septodont · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
90d
Days
Class 2
Risk

K885007 is an FDA 510(k) clearance for the CIMPAT S TEMPORARY DENTAL CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on March 1, 1989 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Specialites Septodont devices

Submission Details

510(k) Number K885007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1988
Decision Date March 01, 1989
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EMA Cement, Dental

All 287
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K885007.
BANDTITE GLASS IONOMER CEMENT
K896249 · American Orthodontics · Jan 1990
KULZER GLAS-IONOMER CEMENT
K892453 · Kulzer, Inc. · Dec 1989
TEMP BOND NE
K894219 · Kerr Corporation (Danbury) · Sep 1989
CHELON-FIL
K884475 · Espe GmbH (Us) · Dec 1988
INTERIM, TEMPORARY CEMENT
K884081 · Scientific Pharmaceuticals, Inc. · Dec 1988
KERR XR BOND
K880250 · Kerr Corporation (Danbury) · Jun 1988