Cleared Traditional

K844846 - ESPE KETAC-CEM RADIOPAQUE

K844846 is an FDA 510(k) clearance for ESPE KETAC-CEM RADIOPAQUE, manufactured by Espe GmbH (Us). The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K844846 · Espe GmbH (Us) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K844846

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
Combination Product No
PCCP Authorized No
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.

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 433
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K844846.
ZIONOMER CEMENT
K852196 · Den-Mat Corp. · Jun 1985
76 EMA LINING CEMENT
K851468 · G-C Intl. Corp. · May 1985
GLAS IONOMER CEMENT
K850913 · Shofu Dental Corp. · Apr 1985
KETAC-SILVER
K843566 · Espe GmbH (Us) · Dec 1984
KERR RESIN BONDED BRIDGE CEMENT
K840407 · Sybron Corp. · May 1984
GLAS IONOMER CEMENT
K841195 · Shofu Dental Corp. · May 1984