Cleared Traditional

ESPE KETAC-CEM RADIOPAQUE (K844846) - FDA 510(k) Clearance

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

K844846 · Espe GmbH (Us) · Dental device
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Mar 1985
Decision
102d
Days
Class 2
Risk

K844846 is an FDA 510(k) clearance for the ESPE KETAC-CEM RADIOPAQUE. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Lake Worth, US). The FDA issued a Cleared decision on March 25, 1985 after a review of 102 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 Espe GmbH (Us) devices

Submission Details

510(k) Number K844846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1984
Decision Date March 25, 1985
Days to Decision 102 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 127d · This submission: 102d
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 K844846.
BONDEX* GLASS IONOMER CEMENT
K870211 · Johnson & Johnson Professionals, Inc. · Mar 1987
MODI. DICOR CASTABLE CERAMIC/ALL PORCELAIN BRIDGES
K864725 · Dentsply Intl. · Jan 1987
3M GLASS IONOMER LINER
K864270 · 3M Company · Dec 1986
CHEMFIL
K812858 · Dentsply Intl. · Dec 1981
CEMENT, CERAMCO
K790127 · Johnson & Johnson Professionals, Inc. · Feb 1979