Cleared Traditional

K881661 - IONOSCEM OR IONOSCELL GLASS IONOMER DENTAL CEMENT

K881661 is an FDA 510(k) clearance for IONOSCEM OR IONOSCELL GLASS IONOMER DEN..., manufactured by Specialites Septodont. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K881661

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
Combination Product No
PCCP Authorized No
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.

EMA Device Classification - Class 2, Special Controls

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 430
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K881661.
COE PAK AUTO MIX, REGULAR OR HARD SET
K881422 · Coe Laboratories, Inc. · Oct 1988
PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT
K881890 · Specialites Septodont · Jul 1988
LIGHT-CURED ZIONOMER CEMENT
K881918 · Den-Mat Corp. · Jul 1988
KERR XR BOND
K880250 · Kerr Corporation (Danbury) · Jun 1988
KERR XR IONOMER
K880251 · Kerr Corporation (Danbury) · Jun 1988
FUJI CAP II CAPSULE & APPLIER
K880848 · G-C Intl. Corp. · May 1988