Cleared Traditional

K881661 - IONOSCEM OR IONOSCELL GLASS IONOMER DEN...

K881661 is the FDA 510(k) clearance for IONOSCEM OR IONOSCELL GLASS IONOMER DEN... by Specialites Septodont. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K881661 · Specialites Septodont · Dental device
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Jun 1988
Decision
53d
Days
Class 2
Risk

K881661 is an FDA 510(k) clearance for the IONOSCEM OR IONOSCELL GLASS IONOMER 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 June 7, 1988 after a review of 53 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Specialites Septodont devices

Submission Details

510(k) Number K881661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1988
Decision Date June 07, 1988
Days to Decision 53 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 127d · This submission: 53d
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 K881661.
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
KERR XR IONOMER
K880251 · Kerr Corporation (Danbury) · Jun 1988
PORCELITE DUAL CURE CEMENT
K880685 · Kerr Corporation (Danbury) · May 1988