Cleared Traditional

K984248 - PROCEM

K984248 is an FDA 510(k) clearance for PROCEM, manufactured by Espe Dental AG. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K984248 · Espe Dental AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
42d
Days
Class 2
Risk

K984248 is an FDA 510(k) clearance for the PROCEM. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Espe Dental AG (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on January 8, 1999 after a review of 42 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Espe Dental AG devices

FDA 510(k) Submission Details - K984248

510(k) Number K984248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1998
Decision Date January 08, 1999
Days to Decision 42 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 127d · This submission: 42d
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 431
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K984248.
IONOSIT BOND
K991172 · Dmg Chemisch Pharmazeutische Fabrik GmbH · May 1999
HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010
K990155 · Kay See Dental Mfg. Co. · Feb 1999
MIRACLE MIX POWDER/LIQUID
K984505 · GC America, Inc. · Feb 1999
STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281
K984340 · Sterngold/Implamed · Jan 1999
ALUMINA-ZINC OXIDE POWDERS F AND R
K983752 · Harry J. Bosworth Co. · Dec 1998
PANAVIA F
K983361 · Kuraray America, Inc. · Nov 1998