Cleared Traditional

K883698 - ZINC OXIDE EUGENOL TEMPORARY CEMENT

K883698 is an FDA 510(k) clearance for ZINC OXIDE EUGENOL TEMPORARY CEMENT, manufactured by E&D Dental Manufacturing Co.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K883698 · E&D Dental Manufacturing Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1988
Decision
91d
Days
Class 2
Risk

K883698 is an FDA 510(k) clearance for the ZINC OXIDE EUGENOL TEMPORARY CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by E&D Dental Manufacturing Co. (Hillside, US). The FDA issued a Cleared decision on November 29, 1988 after a review of 91 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 E&D Dental Manufacturing Co. devices

FDA 510(k) Submission Details - K883698

510(k) Number K883698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1988
Decision Date November 29, 1988
Days to Decision 91 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: 128d · This submission: 91d
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 437
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K883698.
CHELON-FIL
K884475 · Espe GmbH (Us) · Dec 1988
INTERIM, TEMPORARY CEMENT
K884081 · Scientific Pharmaceuticals, Inc. · Dec 1988
RESUBMITTED EMA DENTIN CEMENT
K883770 · G-C Intl. Corp. · Nov 1988
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