Cleared Traditional

SUMO GLASS IONOMER CEMENT (K913519) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K913519 · Ortho Source · Dental device
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Nov 1991
Decision
104d
Days
Class 2
Risk

K913519 is an FDA 510(k) clearance for the SUMO GLASS IONOMER CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Ortho Source (North Hollywood, US). The FDA issued a Cleared decision on November 19, 1991 after a review of 104 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 Ortho Source devices

Submission Details

510(k) Number K913519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1991
Decision Date November 19, 1991
Days to Decision 104 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 127d · This submission: 104d
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 80
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K913519.
MULTIPURPOSE RESIN CEMENT
K923473 · Dentsply Intl. · Apr 1993
3M VITREMER TRI-CURE GLASS IONOMER SYSTEM
K925032 · 3M Company · Dec 1992
VENEER CEMENT
K923328 · Dentsply Intl. · Sep 1992
VLC GLASS IONOMER
K913836 · Dentsply Intl. · Oct 1991
3M LUTING CEMENT, PASTE A AND B
K911842 · 3M Company · Jun 1991
CHEMFIL II CAPS
K901524 · Dentsply Intl. · Sep 1990