Cleared Traditional

ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) (K933543) - FDA 510(k) Clearance

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

K933543 · Jedental Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
104d
Days
Class 2
Risk

K933543 is an FDA 510(k) clearance for the ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT). Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Jedental Co., Inc. (Southampton, US). The FDA issued a Cleared decision on November 1, 1993 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 Jedental Co., Inc. devices

Submission Details

510(k) Number K933543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1993
Decision Date November 01, 1993
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 K933543.
NEW LUTING CEMENT MATERIAL (NLC)
K940914 · Dentsply Intl. · Aug 1994
MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF)
K940459 · Dentsply Intl. · Apr 1994
3M VITREMER LUTING CEMENT
K933139 · 3M Company · Jan 1994
VARIGLASS VLC GLASS IONOMER
K931229 · Dentsply Intl. · Jul 1993
MULTIPURPOSE RESIN CEMENT
K923473 · Dentsply Intl. · Apr 1993
3M VITREMER TRI-CURE GLASS IONOMER SYSTEM
K925032 · 3M Company · Dec 1992